MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number BLIS-X1

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

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Per the reporter, the device is not available for evaluation.The investigation is ongoing.On (b)(6) 2021, bausch + lomb received an email from sheila connors at cdrh/food and drug administration notifying the company that the report initially submitted on (b)(6) 2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

It was reported after an intraocular lens (iol) was implanted into the right (od) eye, the surgeon noticed a scratch at the center of the optic.The incision was enlarged to 3.0mm to explant the iol.A back up iol of the same model and diopter power was successfully implanted intraoperatively.Two sutures were used.The patient did not notice a decrease in vision.In the surgeon's opinion, the most likely cause of the event is due to folding/unfolding of the lens, however the surgeon indicated there was no difficulty in loading or injecting the lens.The patient's outcome is good.

Manufacturer Narrative

Per the reporter, the device was not available for return, therefore no product evaluation was possible.As the lot number is unknown, the associated device history record (dhr) was unable to be reviewed.A review of nonconformances found no similar events that would have contributed to the reported event.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The most probable root cause for this event may be user related as the scratch of the iol may be due to the insertion of the cartridge into the injector.A slightly shifted insertion may cause a mismatch between the hard plunger and the iol.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11592389
• MDR Text Key: 243128571
• Report Number: 0001313525-2021-00044
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K131958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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 Model Number: BLIS-X1
• Device Catalogue Number: BLIS-X1
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL, AMVISC PLUS VISCOELASTIC
• Patient Outcome(s): Required Intervention