FDA Adverse Event Other Summary report: N

CAPSULORHEXIS FORCEPS AND FORCEPS, OPHTHALMIC

MDR report key: 21322212 · Received February 6, 2025

Report

Report Number
MW5165672
Event Type
Other
Date Received
February 6, 2025
Report Date
August 14, 2024
Manufacturer
BAUSCH & LOMB
Product Code
HNR
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

A REPORTER CALLED TO SUBMIT A COMPLAINT ABOUT BAUSCH & LOMB¿S BUSINESS PRACTICES. HE DID NOT WANT TO PROVIDE HIS NAME BECAUSE HE STILL WORKS FOR THE COMPANY. HE SAID HIS COMPANY IS IMPORTING THE FORCEPS FROM CHINA TO DO THE FINISHING. THE PRODUCTS THAT ARE COMING FROM CHINA ARE NOT MADE TO THE SPECIFICATIONS. THEY ARE TOO LARGE IN THE FRONT END. HE SAID WHEN THEY COMPLAIN, THE MANAGERS TELL THEM TO SEND THEM OUT SINCE THEY ARE IN BACK ORDER. HE SAID IN THEIR TRAINING THEY ARE NOT SUPPOSED TO DO THAT. HOWEVER, THEY ARE TOLD TO SEND THOSE DEFECTIVE DEVICES OUT TO THE CONSUMERS ANYWAY. HE SAID THEY RECEIVE COMPLAINTS FROM CONSUMERS. HE GAVE AN EXAMPLE WHAT ONE DOCTOR SAID, WHEN HE WAS USING THE FORCEPS, IT WAS STRESSING ON THE WOUND SINCE IT WAS TOO LARGE. HE WENT ON SAYING THAT THERE IS AN ISSUE WITH THEIR SUCTION TUBES ALSO. AGAIN, THE SUPERVISOR OF THAT DEPARTMENT TOLD THEM THERE IS NOTHING WRONG WITH THE INSTRUMENTS. HE SAID THIS IS NOT THE COMPANY HE CAME TO WORK WITH 38 YEARS AGO SO HE IS HOPING THIS PRACTICE WILL STOP. THE FACILITY ADDRESS IS BAUSCH & LOMB INC, 499 SOVEREIGN COURT MANCHESTER, MO 63011.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1532837 CAPSULORHEXIS FORCEPS AND FORCEPS, OPHTHALMIC FORCEPS, OPHTHALMIC HNR BAUSCH & LOMB E2002 M

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown