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

Model Number BLIS-X1

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

Patient Problem Capsular Bag Tear (2639)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned and evaluated.The lens was in a dried condition in the compression zone of the delivery device cartridge.Visual inspection found both haptics bent.Functional testing could not be performed due to the lens being stuck in the device.A review of the device history records is in progress.The investigation is ongoing.The investigation is ongoing.A follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that the during lens implantation the capsule bag tore.A vitrectomy was performed and a backup lens of different model and diopter was implanted.A vitrectomy was performed, the incision was not enlarged and the plan of surgery was not changed.The patient¿s current prognosis is normal, as expected with any cataract surgery textbook case.Additional information has been requested, but not received.

Event Description

Additional information was received indicating patient was involved in a car accident as a pedestrian, which required them to have the initial phacoemulsification surgery.

Manufacturer Narrative

Additional information was received indicating patient was involved in a car accident as a pedestrian, which resulted in eye damage and a phacoemulsification surgery.The capsule damage was noticed during lens implant rotation; however, the tear most likely occurred during the accident which caused eye damage and therefore the need for a phacoemulsification surgery.Based on the available information, this event no longer meets the reportability requirements as it is not related to the reported device.

• 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: 11761533
• MDR Text Key: 248652526
• Report Number: 0001313525-2021-00058
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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 Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA INTRAOCULAR LENS; ENVISTA INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR