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

Model Number EZ-24

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

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the product is not available to be returned for evaluation.Though requested, no additional event information has been received.As the product lot number is unknown, no review of the device history record could be performed.The investigation is ongoing.

Event Description

It was reported that after implantation of the intraocular lens (iol) into the eye, a hole in the posterior wall was observed.The iol was removed intraoperatively, with no requirement of incision enlargement or sutures.A posterior vitrectomy was performed.A back-up lens of the same model and different diopter was successfully implanted.

Manufacturer Narrative

The product was not returned for evaluation.A review of nonconformances (ncs) two years prior to event date was performed.There were no ncs that would contribute to the reported complaint issue.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.

Event Description

This report is regarding the patient¿s right eye.Though requested, no additional information has been provided.

• 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
• MDR Report Key: 10631812
• MDR Text Key: 209964895
• Report Number: 0001313525-2020-00151
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K132481
• 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: 01/01/2005,09/10/2020

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: EZ-24
• Device Catalogue Number: EZ-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT IOL
• Patient Outcome(s): Required Intervention