MAUDE Adverse Event Report: BAUSCH + LOMB KELMAN-MCPHERSON TYING FORCEPS ANGLED; FORCEPS, OPHTHALMIC

Model Number E1815 AKUS

Device Problems Flaked (1246); Particulates (1451)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The instrument has been returned and the evaluation is in progress.The investigation is ongoing.

Event Description

A user facility in (b)(6) reported that the doctor found some shining and uncertain material inside the patient's eye during a post-surgery follow up.The doctor noted that the material looked similar to the coating of the instrument used during surgery.The doctor did not remove the material from the patient's eye and the patient did require medical intervention/treatment.No further information is available for this case, including the patient's current status.

Manufacturer Narrative

The product evaluation did not substantiate the complaint.Visual inspection (using both the naked eye and a unitron zoom hd microscope under 30x power) of the returned product sample indicated the forceps did not show any signs of flaking material.The returned product was compared to the master model and shown to be in compliance.The alignment of the forceps was in specification and the forceps met all functional and dimensional requirements.The evaluation of the returned product sample demonstrated that it was not a source of the reported unknown foreign material in the patient''s eye.A review of the last four lots of the e1815 akus forceps showed all forceps complied with manufacturing requirements, including ensuring the 17-4 stainless steel used was appropriately hardened.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.

• Brand Name: KELMAN-MCPHERSON TYING FORCEPS ANGLED
• Type of Device: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11314066
• MDR Text Key: 233489793
• Report Number: 0001920664-2021-00010
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E1815 AKUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR