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

Model Number EZ-28V

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is still in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that during a lens implant, haptics were missing after the lens was injected into the eye and they were left in the injector.There was no damage to the capsular bag or loss of vitreous fluid.The incision was enlarged and sutures were required.Another model lens was implanted with no issues.The prognosis of the patient is good.

Manufacturer Narrative

Additional information: the device history record (dhr) was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.The lens was returned to b+l for evaluation.Visual inspection found one haptic has been torn from the optic and is missing.The other haptic is bent.The missing haptic was found caught in and sticking out of the closed drawer.Functional testing cannot be performed due to the damage.Based on the current information, the root cause of the event could not be conclusively determined; however, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

Manufacturer Narrative

The device history record (dhr) was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.One ez-28v delivery device was returned to b+l in the lens box with the tip bent.Visual inspection found one haptic has been torn from the optic and is missing.The other haptic is bent.The missing haptic was found caught in and sticking out of the closed drawer.Based on the current information, the root cause of the event could not be conclusively determined; however, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 7949640
• MDR Text Key: 123191122
• Report Number: 0001313525-2018-00176
• 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,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: EZ-28V
• Device Lot Number: H850801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT INTRAOCULAR LENS
• Patient Outcome(s): Other
• Patient Age: 81 YR