MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB IOL INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number 21987_B10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Per the reporting facility, the device is not available for evaluation.

Event Description

It was reported that during implantation of an intraocular lens (iol) into the left (os) eye, it was noticed intraoperatively that the trailing haptic was severed.The incision original size of 2.4mm was enlarged to 3.0mm for iol removal.A successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Sutures were required.The patient did not notice a decrease in vision at the 1 week post op visit.In the surgeon's opinion, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.The patient's outcome is good.

Manufacturer Narrative

Per the reporting facility, the device is not available for return.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.A review of the device history records (dhr) did not find any non-conformities or anomalies to the related to this event.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

• Brand Name: BAUSCH + LOMB IOL INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11574369
• MDR Text Key: 249732360
• Report Number: 0001313525-2021-00035
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K113852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 21987_B10
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL, PROVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR