MAUDE Adverse Event Report: BAUSCH + LOMB, INC. ENVISTA SIMPLIFEYE INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number 21987

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

Patient Problems Edema (1820); No Code Available (3191)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the device was discarded and is not available for evaluation.A device history record (dhr) review, did not find any non-conformities or anomalies that would have caused or contributed to the reported complaint.The lot/device history review and trend analysis are considered acceptable and the product is performing within anticipated rates.In the surgeon¿s opinion, the most likely cause of the iol damage was due to the plunger making the scratch in the optic.The most likely root cause for this event is operational context.User-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to this event.No corrective action is necessary at this time.

Event Description

It was reported that during a procedure an intraocular lens (iol) was inserted in the patient¿s eye, when in the capsular bag it was noted that there was a scratch on the optic.The iol was removed from the patient''s eye after enlarging the incision and no sutures were required.The original incision size was 2.2 mm and it was enlarged to approximately 2.8mm to remove the lens.The duration of the surgery was extended by approximately half an hour.A second iol of a different model was implanted.The patient reported edema post-surgery, which was resolved within one week.In the surgeon''s opinion, the most likely cause of the iol damage was due to the injector making the scratch in the optic.

• Brand Name: ENVISTA SIMPLIFEYE INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd,; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 11130524
• MDR Text Key: 225500851
• Report Number: 0001313525-2021-00004
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2020

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: 02/28/2023
• Device Model Number: 21987
• Device Catalogue Number: 21987
• Device Lot Number: 1967A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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
• Treatment: ENVISTA INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention