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 Visual Impairment (2138); Halo (2227)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported that both haptics were cut while implanting an iol into the right eye of the patient, therefore the lens was de-centered.This incident was reported as a loading error by the nurse.Patient was experiencing dysphotopsia (halos) caused by the de-centration of the lens.The lens was explanted four weeks post-op and replaced with a similat model and diopter lens.The main incision had to be enlarged from 2.74 to 3.1 mm without needing sutures.

Manufacturer Narrative

Additional info: g4, h2, h6, h10.Although requested, the device was not returned for evaluation.A lot number for the reported device was not provided and therefore a device history record (dhr) review could not be performed.Complaint trends for this failure mode were reviewed and the volume of complaints is within the acceptable control limits and no complaint trend is observed.Issues during the loading process can lead to torn haptics indicated by the hard plunger rod and the neglecting of the loading instructions.It is noteworthy to mention that an off label iol was used with this injector.The most probable root cause is user error.No further action is necessary.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 10731122
• MDR Text Key: 212972947
• Report Number: 0001313525-2020-00159
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FINE VISION INTRAOCULAR LENSES
• Patient Outcome(s): Required Intervention