KOCH STOP CHOP MANIPUL 12B SUF01Recalls & reported problems

Bausch & Lomb GmbH · Single Use Medical Device for Ophthalmic Surgery · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04058935005108), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 12, 2025Break; Break
THE USER FACILITY IN GERMANY REPORTED THE TIP OF THE CHOPPER BROKE AND ENTERED THE PATIENT'S EYE. THIS PIECE WAS REMOVED WITH A FORCEPS. THERE WAS NO PATIENT IMPACT, AND NO ADDITIONAL ANESTHESIA REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037100 ↗

Device details

UDI-DI	`04058935005108`
Brand	KOCH STOP CHOP MANIPUL 12B
Model	SUF01
Company	Bausch & Lomb GmbH
Product code	HND · Spatula, Ophthalmic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 17, 2024

Device type (GMDN): Ophthalmic surgical probe, single-use

A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.

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Oph.Spatula 08-14502
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All Spatula, Ophthalmic devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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