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

Model Number BLIS-X1

Device Problem Ejection Problem (4009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.As a device lot number was not provided, a review of the device history record (dhr) could not be performed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.

Event Description

It was reported that during implantation of an intraocular lens (iol) into the right eye the trailing haptic got stuck in the injector and broke off as the lens was being delivered into the eye.The incision was enlarged to allow for removal of the iol and a successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Sutures were not required.The patient outcome is good.Additional information regarding the details of this event was requested, but not received.

Event Description

Additional information was received indicating the incision size was enlarged with a diamond keratome to 2.4mm which is standard range for incision enlargement.

Manufacturer Narrative

Based on additional information received this event no longer meets reportability requirements and is no longer deemed reportable.

• 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
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15939968
• MDR Text Key: 305062994
• Report Number: 0001313525-2022-00183
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2022
• 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: BLIS INJECTION SYSTEM, PROVISC VISCO, BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female