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 Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.Investigation is ongoing and a follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that after the implantation of an intraocular lens in the left eye, capsular bag broke causing vitreous loss.A vitrectomy was performed one day post-op and the lens was exchanged with a three-piece lens.Patient outcome is good.Additional information has been requested.

Manufacturer Narrative

Additional was information received indicating the device causality was unrelated, and therefore, this event no longer meets reportability requirements and no longer deemed reportable.

Event Description

Additional information received indicating that in the surgeon's opinion the most likely cause of the event was the fluid burst, which is related to the handpiece and i/a.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15799476
• MDR Text Key: 303668145
• Report Number: 0001313525-2022-00172
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female