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

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Though requested, the product has not been returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The investigation is ongoing.

Event Description

It was reported that during the insertion of an intraocular lens (iol) into the eye, the haptic on one side tore off.The lens was removed intraoperatively, requiring enlargement of the incision (originally 5.5 mm to 6 mm) and three sutures.The patient experienced a posterior capsule rupture.Implantation of the backup lens was attempted, but was not successful.The patient is aphakic with re-implantation postponed due to patient injury.Additional information has been requested from the reporter, but has not been received.

Manufacturer Narrative

In medical safety opinion, the vitrectomy was performed due to capsule damage caused by patient movement before lens insertion.Therefore the capsule damage had occurred prior to lens implant and is unrelated to the device.Further, the original incision was almost twice the size of the required standard incision for implanting the intraocular lens (iol).No explanation was provided by the reporter as to why this incision size was selected.The adverse events are deemed unrelated to the device.Based on the additional information received by the reporting facility this event no longer meets reportability requirements.As such, this case has been determined to be no longer reportable to the fda.Though requested, the product has not been returned for evaluation.This investigation centers around the root cause for the damaged haptics, as the subsequent patient injury was procedurally related and unrelated to the device.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.The most probable root cause is operational context.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.No corrective action is necessary at this time.

Event Description

It was reported a phacoemulsification to the right eye (od) was performed.The intraocular lens (iol) optic was free and clear of debris/deposits.According to the reporter, no information is available as to why the original incision size was selected.A secondary surgical intervention of a vitrectomy was performed as a result of prolonged elapsed surgical time and patient movement causing capsular rupture prior to lens implantation.The patient noticed a decrease in vision as no lens was re-implanted.In the surgeon's opinion, the likely cause of the event was the haptic was crimped upon insertion and thus lens implantation was prohibited.The patient is doing well post-op with an iol placement to be scheduled.

• 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: 10637890
• MDR Text Key: 211242918
• Report Number: 0001313525-2020-00152
• 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: 01/01/2005,09/09/2020

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 Expiration Date: 12/03/2020
• Device Model Number: EZ-28V
• Device Catalogue Number: EZ-28V
• Device Lot Number: H973601
• 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: 09/09/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LI61AOR2300 SOFPORT IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR