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

Model Number 21987

Device Problem Use of Device Problem (1670)

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

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned 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.No similar events have been reported for this product lot.The exact root cause of the event could not be conclusively determined; however, the directions for use that accompanies this product noted that the viscoelastic used is not validated for use with the inserter.Therefore, the most probable root cause is user error.No corrective action is necessary at this time.

Event Description

It was reported that during a phacoemulsification procedure of the left eye, two (2) surface scratches at 90 degrees to each other were located on the optic of the intraocular lens (iol) when it was delivered into the patient¿s eye.The iol was split and replaced intraoperatively with another model iol.The incision was enlarged from 2.4mm to 2.6mm to remove the iol.Sutures were not required.There was no decrease in patient¿s vision and no other patient injury was reported.In the physician¿s opinion the most likely cause of the iol damage is damaged while shuttle docking or production error.Additional information is requested.

Manufacturer Narrative

The preloaded delivery device was returned and the shuttle was attached to the delivery device.The cartridge tip was damaged as there was evidence that it was stretched on the side.The tip was not fully split but it was thinned in the stretched area.The forked tip of the plunger rod was advanced up into the cartridge tip, but was not protruding from the end.Functional testing could not be performed as the shuttle cannot be removed once properly attached.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 exact root cause of the event could not be conclusively determined.However, it is noteworthy to mention that the viscoelastic used is not validated for use with this system.

Manufacturer Narrative

The device was not returned 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.The exact root cause of the event could not be conclusively determined; however, it is noteworthy to mention that the viscoelastic used 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: 10978257
• MDR Text Key: 220531335
• Report Number: 0001313525-2020-00186
• 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: 11/11/2020

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: 04/30/2023
• 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: 02/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: Not provided; 02/24/2021
• Supplement Dates FDA Received: 02/18/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTAIOL, MEDIO-CLEAR 2,4% / 1,6%; ENVISTAIOL, MEDIO-CLEAR 2,4% / 1,6%
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR