MAUDE Adverse Event Report: KATENA PRODUCTS, INC. OPHTHALMIC FORCEPS; KT5-5081

Model Number	KT5-5081
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026 that during use the coating of the forceps came off and went into the patient's eye.The coating was removed intra-op successfully and there were no injuries or post-operative complications reported.
Additional Manufacturer Narrative
Sterile samples from the reported lot, including the actual devices, were not returned for visual review or analysis.Without the actual reported devices, photos of the devices, or detailed information on the method used to remove the device from the packaging, preoperative preparation of the device, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: OPHTHALMIC FORCEPS
• Common Device Name: KT5-5081
• Manufacturer (Section D): KATENA PRODUCTS, INC.; 6 campus dr; suite 310; parsippany NJ 07054
• Manufacturer (Section G): KATENA PRODUCTS, INC.; 6 campus drive; suite 310; parsippany NJ 07054
• Manufacturer Contact: virnalisa cobacha ; 2755 canyon boulevard; 1st floor; boulder, CO 80302
• MDR Report Key: 24837572
• Report Number: 3010692967-2026-00011
• Device Sequence Number: 9221791
• Product Code: HNR
• UDI-Device Identifier: 00841668111307
• UDI-Public: 00841668111307
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KT5-5081
• Device Lot Number: L2405J000056344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown