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 Floaters (1866); Blurred Vision (2137); Eye Pain (4467)

Event Date 02/14/2022

Event Type  Injury  

Event Description

Reportedly, an intraocular lens (iol) was explanted 2 weeks after implant into the left (os) eye due to a broken haptic.The patient stated the eye was throbbing, had floaters, and blurred vision.The surgeon noted the iol damage was noticed postoperatively and was allegedly a mechanical breakdown of the iol.A successful lens exchange using the same model and diopter lens was completed.Additional information has been requested of the reporter.

Manufacturer Narrative

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

Event Description

Additional information was received indicating the patient noticed a decrease in vision.In the physician's opinion, the most likely cause of the intraocular lens (iol) damage was a mechanical breakdown causing displacement of the iol.The patient's outcome is good, and the patient is doing great.

Manufacturer Narrative

According to the reporting facility, the device is not available to be returned for evaluation.A lot number was not provided; therefore, a device history record (dhr) review 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 provided, a root cause for the reported event could not be determined.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 14730881
• MDR Text Key: 294240372
• Report Number: 0001313525-2022-00079
• 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: 05/19/2022

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/19/2022
• 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: ENVISTA IOL, BLIS INJECTOR.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female