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

Model Number EZ-28V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Iritis (1940)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Reportedly, approximately one week after implantation of the intraocular lens (iol) the patient had iritis.The iol was explanted approximately 3 weeks later.Additional information has been requested.

Manufacturer Narrative

The device is not available to be returned.The investigation is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

Additional information was received indicating the patient had iritis when the intraocular lens (iol) was implanted.Due to the iritis, the patient had anisometropia and the iol was explanted.In the surgeon''s opinion, the likely cause of the event was that the wrong diopter was implanted.

Manufacturer Narrative

Additional information was received indicating patient had a history of acute iritis, and therefore the device causality is unrelated.This event does not meet reportability requirements and is no longer deemed 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: 15542614
• MDR Text Key: 301164256
• Report Number: 0001313525-2022-00135
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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: EZ-28V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention