MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60PL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Though requested, the device has not been returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.According to the available information, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.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.

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.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 11574355
• MDR Text Key: 252314797
• Report Number: 0001313525-2021-00034
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 08/31/2023
• Device Model Number: MX60PL
• Device Catalogue Number: MXUEPL1750
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR