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

Model Number EZ-28V

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Though requested, the product was not returned for evaluation.As the lot number is unknown, the device history record cannot be reviewed.The investigation is ongoing.

Event Description

It was reported that after the intraocular lens (iol) was implanted the patient¿s capsule broke, requiring an anterior vitrectomy.The incision was enlarged from 2.8 to 3.2mm to facilitate intraoperative removal of the lens, requiring two nylon 10.0.A sutures.The patient was left aphakic.Though requested, no additional information has been provided.

Event Description

The inserter was observed to have a crack and the trailing haptic was caught.As such, they were unable to successfully implant the lens.Although requested, additional information has not been provided.

Manufacturer Narrative

Additional information to b5, g4, h2, h6, h10/11.A review of nonconformities (ncs) for the past twelve-months was performed.There were no ncs that would contribute to the reported complaint issue.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided, we are unable to determine a root cause.No corrective action or additional investigation is necessary at this time.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 10605592
• MDR Text Key: 209141975
• Report Number: 0001313525-2020-00144
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/03/2020

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-28V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 09/03/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT SQUARE EDGE INTRAOCULAR LENS; SOFPORT SQUARE EDGE INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention