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 Problems Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Though requested, the inserter was not returned for evaluation.A device history record review could not be performed as no lot number was provided.Based upon the complaint trend review this product is within the acceptable control limits and no complaint trends were observed.The risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.A definitive root cause cannot be determined.The most probable root cause is operational context.The iol damage may have occurred if the user misaligned the injector cartridge between the hard plunger and iol when clicking the cartridge into the injector.No corrective action is necessary at this time.

Event Description

It was reported that an intraocular lens (iol) was explanted from the patient¿s eye approximately thirteen months post-implant due to a mark on the iol.The lens was explanted and replaced with a different model lens.The incision was enlarged and 10-0 nylon suture was used.No other patient impact was reported.Though requested, no additional information has been received.

Event Description

Further information indicates that the patient experienced blurred vision and post-operative myopia subsequent to the implant surgery, despite a visual acuity of 20/20.The patient noticed a decrease in their vision.The iol optic was not clear and free of debris and deposits, as the physician noticed a surface anterior central mark on the lens with paracentral opacity.The patient had one yag three months post-implant and one yag four months post-implant with no symptom resolution.A vitrectomy was performed during the explant surgery thirteen months postoperatively.The physician was unable to indicate a likely cause for the event.The patient¿s current prognosis and outcome is good.

Manufacturer Narrative

Although requested, the device was not return for evaluation.The findings reported in our previous submission remain unchanged.

• 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: 10868877
• MDR Text Key: 217920431
• Report Number: 0001313525-2020-00171
• 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: 10/21/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL; PROVISC, ALCON BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR