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

Model Number EZ-28V

Device Problem Device Handling Problem (3265)

Patient Problem Eye Injury (1845)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Product evaluation has been completed.One delivery device from lot h953501 was returned.The lens was in the carrier with both haptics bent.There was very little dried solution visible in the loading deck and none in the tip.Functional testing was performed using a sample lens.The lens loaded and delivered without difficulty.The reported problem was not duplicated.No problem was found.The inserter was not damaged and functioned as designed.No nonconformities were found involving this complaint type or product lot.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.There is no known device problem.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

The doctor noticed that the trailing haptic was bent upon intraocular lens (iol) insertion.The lens was removed and replaced with the same model and diopter lens.The incision was enlarged to remove the lens, and sutures were needed due to the incision enlargement.The original incision size was 2.85 ml.The enlargement was not measured.The type and number of sutures are unknown.No other complications were experienced during the surgery.The orientation of the lens did not change.The iol optic was free and clear of debris/deposits.In the surgeon's opinion, the likely cause of the event was the bent haptic.The patient has a good current prognosis.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 9099385
• MDR Text Key: 163604745
• Report Number: 0001313525-2019-00150
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K970727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/26/2019

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: 05/20/2020
• Device Model Number: EZ-28V
• Device Lot Number: H953501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• 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: 08/26/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR