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

Model Number 21987

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

The surgeon reported while implanting the intraocular lens (iol) that the trailing haptic had sheared off in the small area of the conicle tip and remained in the injector when the iol was implanted.The trailing haptic was almost upright and only became visible after implantation.The iol was removed from the eye after enlarging the incision and no sutures were required.The original incision size was 2.4mm and it was enlarged using a keratome to an unknown size to remove the lens.No sutures were required.The duration of the surgery was not extended.A second iol of the same model and diopter was implanted and surgeon reports observing a crack in the haptic at the optic/haptic junction (fenestration hole).This iol remains implanted and it was reported that there is no known patient impact.Patients current prognosis and treatment is standard with no special requirements.Additional information has been requested and not received.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection found one torn haptic caught in between the inside wall of the tip and the plunger rod of the delivery device.Due to the condition received, functional testing could not be performed.The device history record review did not find any anomalies or non-conformities related to this event.The investigation of this event is in progress and a follow-up report will be submitted upon completion of investigation.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection found, one torn haptic caught in between the inside wall of the tip and the plunger rod of the delivery device.The plunger is advanced passed the haptic and is up into the tip.It was also observed, that the plunger was not fully retracted back into the body.Which bent the fork, while docking the shuttle and caused the fork to not engage, the iol as intended.Due to the condition received, functional testing could not be performed.The lot trend analysis and risk analysis review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.However, as the plunger was not fully retracted back into the body, user related factors might have contributed to the event.

• Brand Name: 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: 11037567
• MDR Text Key: 222359961
• Report Number: 0001313525-2020-00202
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

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 Model Number: 21987
• Device Catalogue Number: 21987
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: Not provided; 02/19/2021
• Supplement Dates FDA Received: 02/12/2021; 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIMPLIFEYE PRELOADED ENVISTA IOL; SIMPLIFEYE PRELOADED ENVISTA IOL
• Patient Outcome(s): Required Intervention