Ophthalmic Spatula K3-2538Recalls & reported problems

Katena Products, Inc. · INTRALASE FLAP LIFTER DOUBLE ENDED · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841668103210), received between Jan 24, 2024 and Jan 24, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Fragmentation1

Patient problems

Discomfort1
Visual Disturbances1

Recent adverse event reports

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

InjuryJan 24, 2024Material Fragmentation; Material Fragmentation
ON 26-DEC-2023, A DISTRIBUTOR FROM FRANCE INFORMED CORZA MEDICAL CUSTOMER SERVICE REPRESENTATIVE THAT THEY RECEIVED A COMPLAINT FROM THEIR CUSTOMER AGAINST K3-2538 INTRALASE FLAP LIFTER DOUBLE. THE DISTRIBUTOR STATED THAT ON (B)(6) 2022, THE CUSTOMER PURCHASED 6 MANIPULATORS. THESE MANIPULATORS ARE USED BY A SINGLE DOCTOR WHO PERFORMS MULTIPLE PROCEDURES ONCE A MONTH. OVER SEVERAL MONTHS, THE SURGEON NOTICED METAL DEPOSITS IN THE POSTOPERATIVE INTERFACE. THE DATES OF THESE PROCEDURES WERE ON (B)(6) 2023. THERE ARE MULTIPLE INSTRUMENTS INVOLVED DURING THE PROCEDURES INCLUDING A NON-KATENA MICROMANIPULATOR AND A BLEPHAROSTAT. THE DOCTOR STATED THAT ONE PATIENT EXPERIENCED VISUAL DISCOMFORT AND PHOTIC EFFECTS. THE 6 KATENA K3-2538 INSTRUMENTS WERE REMOVED FROM FUTURE PROCEDURES AND SENT TO KATENA FOR EVALUATION. ON 22-JAN-2023 KATENA (CORZA OPTHALMOLOGY) RECEIVED THE INSTRUMENTS.
Patient problems: Discomfort; Visual Disturbances
MAUDE report 18576893 ↗

Device details

UDI-DI	`00841668103210`
Brand	Ophthalmic Spatula
Model	K3-2538
Company	Katena Products, Inc.
Product code	HND · Spatula, ophthalmic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 16, 2023

Device type (GMDN): Ophthalmic surgical probe, reusable

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 reusable device.

Other Spatula, ophthalmic devices

Oph.Spatula 05-4036
Katena Products, Inc. · Spatula, ophthalmic
1 report
Oph.Spatula 08-14527
Katena Products, Inc. · Spatula, ophthalmic
1 report
Oph.Spatula 08-14502
Katena Products, Inc. · Spatula, ophthalmic
1 report
KOCH STOP CHOP MANIPUL 12B SUF01
Bausch & Lomb GmbH · Spatula, Ophthalmic
1 report

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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