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

Model Number 21987

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

Patient Problem No Code Available (3191)

Event Date 01/28/2021

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 nonconformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use were reviewed and considered acceptable.Based on the available information, the root cause of this event could not be conclusively determined.

Event Description

It was reported that during a phacoemulsification procedure while implanting an intraocular lens (iol), the surgeon found the trailing haptic in the capsular bag.The lens was removed intraoperatively, which required enlargement of the incision from 2.4mm to 3.0mm and sutures in the cornea.The surgery plan was not changed.A replacement lens with the same model and diopter was successfully implanted and resolved the issue.The patient did not notice a decrease in their vision.In the surgeon's opinion, the likely cause of the event are the two sharp ends at the tip of the injector which punctures the lens.It is also mentioned that the lens is thinner than previous model and the fenestration is weaker.

• Brand Name: ENVISTA SIMPLIFEYE INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 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 -, FL 33759 ; 7277246659
• MDR Report Key: 11377206
• MDR Text Key: 242751220
• Report Number: 0001313525-2021-00028
• 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: Physician
• Type of Report: Initial
• Report Date: 01/28/2021

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: 11/30/2023
• Device Model Number: 21987
• Device Lot Number: 1977C4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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