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 Vitrectomy (2643); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow up report will be sent when additional information becomes available.

Event Description

It was reported that the 1-piece intraocular lens (iol) was unstable in the bag and wasn¿t able to be positioned properly in the capsular bag.The lens was fully injected prior to removal.The iol was removed intraoperatively and replaced with a different model and diopter iol.The incision was enlarged to remove the lens and sutures were required.A vitrectomy was performed.No other patient injury was reported.Additional information has been requested.

Manufacturer Narrative

The device was not returned for evaluation.An analysis of production records could not be performed, as no lot number was provided.Based upon the complaint trend review, the volume of complaints is within the acceptable control limits and no complaint trend is observed.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information available a definitive root cause could not be determined.However, the most likely root cause is associated with operational context.The proper loading of the intraocular lens (iol) in accordance with the directions for use (dfu), including the use of adequate amounts of viscoelastic in the cartridge is essential for the performance of the injector and its cartridge.No additional investigation or corrective action is necessary at this time.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11167000
• MDR Text Key: 228699071
• Report Number: 0001313525-2021-00010
• 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
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: BLIS-X1
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC, VISCOAT, ENVISTA INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR