Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Utrata forceps are a family of fine, handheld ophthalmic forceps, also sold as capsulorhexis forceps, that the FDA files under product code HNR as “Forceps, Ophthalmic”, a Class I device under 21 CFR 886.4350. This guide is for clinic staff, buyers and students who need to read an instrument listing correctly: what the name covers, how the FDA classifies it, how reusable and single-use versions differ on the label, and what dimensions manufacturers actually record.
What Utrata forceps are
“Utrata forceps” and “capsulorhexis forceps” are overlapping names used in manufacturer listings. In the FDA’s Global Unique Device Identification Database (GUDID), a typical record is titled “Utrata Capsulorrhexis Forceps, With Cystotome Tips” and is described as 11.5 mm curved jaws on a flat handle in stainless steel (Aurora Surgical, record checked 2026-10-31). Other makers add a second surname to the name, such as O’Gawa-Utrata, Lehner-Utrata or Utrata-Kershner, to describe a particular tip or shaft design.
“Ophthalmic forceps” is the broader group. Utrata-type capsulorhexis forceps are one kind of manual ophthalmic surgical instrument. Who uses them: ophthalmic surgical teams, and the sterile processing and purchasing staff who stock and reprocess their instruments.
How they are built
The GUDID classification term for reusable versions is “Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable” (GMDN 62674). The GMDN definition says such devices are typically made of metal and may have carbide inserts at the working end. Manufacturer descriptions in GUDID name titanium or stainless steel as the material, and mention parts such as angled or vaulted shafts, the tip style (triangular, serrated, sharp cystotome-type or round), the handle style (flat, round, three-hole, fenestrated) and, on some models, a guide pin or iris stop.
Types and variants recorded in GUDID
The table lists examples of how manufacturers describe Utrata-type forceps in GUDID, as returned by the openFDA UDI database on 2026-10-31. Each row is a manufacturer’s own description, not a ranking or recommendation.
| Manufacturer and name in GUDID | Shaft and length | Tips and handle | Material |
|---|---|---|---|
| Aurora Surgical: Utrata Capsulorrhexis Forceps, With Cystotome Tips | 11.5 mm curved jaws | Cystotome tips, flat handle | Stainless |
| Diamatrix: O’Gawa-Utrata Capsulorhexis Forceps | Angled, 12 mm from bend to tip; 105 mm total | Thin triangular grasping tips, diamond knurled handle, guide pin stop | Stainless |
| Med Saver (MSI): Utrata MICS Capsulorhexis Forceps | Angled 13 mm shafts; 4.2 in (107 mm) overall | Fine tips; described for 1.8 mm MICS procedures | Titanium |
| Medetz: Utrata capsulorhexis forceps | Angled shafts; 3 1/4 in | Fine, serrated grasping tips; flat serrated handle | Not stated |
| Ambler Surgical: Utrata MICS capsulorhexis forceps | Vaulted 10.5 mm shanks; 4 5/8 in | 0.25 mm x 0.7 mm triangular tips, guide pin, round handle | Titanium |
| Ambler Surgical: Corydon MICS Utrata capsulorhexis forceps | Vaulted shafts, 12.0 mm from bend to tip; 4 3/8 in | Sharp grasping tips, 2.0 mm maximum tip spread, fenestrated round handle | Not stated |
Reading the variants
Differences recorded in these descriptions fall into four groups: shaft geometry (angled versus vaulted), the bend-to-tip distance (about 10.5 to 13 mm in the records above), tip shape and spread, and handle style. Some listings carry the label MICS in the product name; two Ambler MICS records give maximum tip spreads of 2.0 mm and 1.8 mm.
Dimensions that matter
GUDID records often leave the structured device-size fields empty, so the dimensions sit in the free-text device description. The values worth comparing on a listing are overall length (for example 105 mm, 107 mm, or 3 1/4 in), distance from bend to tip, maximum tip spread where given, and material. Compare these only within the same manufacturer’s own description, since each company words them differently.
FDA class and product code
- Regulation: 21 CFR 886.4350, “Manual ophthalmic surgical instrument”, defined as a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. The regulation lists “ophthalmic forcep” among the generic types it covers (eCFR text via Cornell LII, checked 2026-10-31).
- Classification: Class I (general controls), with the regulation’s exemption text on premarket notification.
- Product code: HNR, “Forceps, Ophthalmic”, device class 1, regulation number 886.4350, ophthalmic panel (openFDA device classification database, checked 2026-10-31).
- Sibling codes under the same regulation include cystotome (HNY), spud (HNA), spatula (HND) and lachrymal dilator (HNW), all Class 1.
Reusable versus single-use
GUDID distinguishes the two in both the GMDN term and the sterility fields. A reusable record such as Aurora Surgical’s states that the device is not packaged sterile, requires sterilization before use (moist heat or steam), and is not single-use. A single-use record, such as Blink Medical’s Utrata capsulorhexis forceps, model 11-5024, is packaged sterile, flagged single-use and carries the GMDN term “single-use” (62673).
In the first 100 records returned by an openFDA UDI query for HNR devices whose description contains “capsulorhexis”, all 100 were labelled for sterilization before use and 2 were flagged single-use. That is a count for that sample only, not a market share.
Safe handling and reprocessing basics
- Follow the manufacturer’s instructions for use for the specific model. The label in GUDID shows whether a unit arrives sterile or needs sterilizing first.
- Do not reprocess a device labelled single-use.
- These are delicate instruments; the descriptions above use words such as “fine”, “delicate” and “very delicate” for the tips, so handle and store them according to the maker’s guidance.
Common mistakes
- Treating “Utrata” as one fixed design. The name appears alongside many shaft, tip and handle variations from different manufacturers.
- Assuming every unit arrives sterile. Most reusable listings are non-sterile and labelled for sterilization before use.
- Mixing up reusable and single-use versions of the same name, which have different GMDN terms and sterility labelling.
- Comparing lengths or tip spreads across listings that measure from different points (overall length versus bend to tip).
Frequently asked questions
Are Utrata forceps the same as capsulorhexis forceps?
The names overlap in manufacturer listings. GUDID records use both “Utrata” and “capsulorhexis” in product names, and some makers add a second surname for a particular tip or shaft design.
What FDA class are Utrata forceps?
They are filed under product code HNR, “Forceps, Ophthalmic”, Class I (general controls) under 21 CFR 886.4350.
Are they reusable or single-use?
Both exist. Reusable records carry GMDN term 62674 and are labelled for sterilization before use; single-use records carry GMDN term 62673 and are packaged sterile.
Related reading
See ophthalmic surgical instruments, the Castroviejo needle holder, the lacrimal probe and the chalazion clamp for other instruments under the same regulation. Instrument categories are also listed under forceps.
Sources
- 21 CFR 886.4350, Manual ophthalmic surgical instrument: https://www.law.cornell.edu/cfr/text/21/886.4350 (checked 2026-10-31)
- openFDA device classification, product code HNR: https://api.fda.gov/device/classification.json?search=product_code:HNR (checked 2026-10-31)
- openFDA UDI database, product code HNR: https://api.fda.gov/device/udi.json?search=product_codes.code:HNR (checked 2026-10-31)
- AccessGUDID record 08175700122740, Aurora Surgical: https://accessgudid.nlm.nih.gov/devices/08175700122740 (checked 2026-10-31)
- AccessGUDID record 05060480407329, Blink Medical: https://accessgudid.nlm.nih.gov/devices/05060480407329 (checked 2026-10-31)
