MAUDE Adverse Event Report: BAUSCH + LOMB EASY-LOAD LENS DELIVERY SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number EZ-28V

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Corneal Abrasion (1789)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Reportedly, while attempting to insert an intraocular lens (iol) into the eye, the surgeon noticed a split at the end of the inserter that caused a corneal abrasion.A back up iol of the same model and diopter was successfully implanted with a new injector, and the patient wore a patch in addition to the normal post op shield to protect the eye.Patient outcome is reportedly good.

Manufacturer Narrative

Device was returned and evaluated.Microscopic examination was performed and found the lens stuck in the cartridge.The cartridge tip was bent and a split on the lower tip was observed.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Manufacturer Narrative

Evaluation of the returned device confirmed there were no split tips on the injector as initially reported.This complaint no longer meets reportability requirements and is not reportable.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15806682
• MDR Text Key: 305501670
• Report Number: 0001313525-2022-00169
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ-28V
• Device Lot Number: H253901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2022
• 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
• Patient Sequence Number: 1
• Treatment: AMVISC PLUSSILICONE IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female