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

Model Number 21987

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the device was discarded and is not available for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that during a phacoemulsification procedure while implanting an intraocular lens (iol) into the right eye, the leading haptic broke.The lens was removed intraoperatively, which required enlargement of the incision from 2.2 mm to 2.6mm and sutures.The surgery plan was not changed.A different model lens was successfully implanted and resolved the issue.The patient did not notice a decrease in their vision.In the physician's opinion, the likely cause of the event is the iol entered the eye with the front haptic broken.

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.It is noteworthy to mention, that the viscoelastic used in this procedure is not validated for use with this system.Based on the available information, the root cause of this event could not be conclusively determined.

• 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
• MDR Report Key: 11045690
• MDR Text Key: 222634399
• Report Number: 0001313525-2020-00204
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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 Lot Number: 1967A1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VISCOELASTIC: HEALON, ENVISTA IOL PL; VISCOELASTIC: HEALON, ENVISTA IOL PL
• Patient Outcome(s): Required Intervention