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

Model Number EZ-28V

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the product was discarded.A review of nonconformances (ncs) for the past year was performed; there are no ncs that would contribute to the reported issue.There are no open ncs or capas associated with the reported issue.The trend analysis, risk analysis and directions for use review 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 that the trailing haptics of an intraocular lens (iol) were damaged during implantation into the left eye, requiring removal of the lens.The patient remained aphakic, as no other lenses were available.According to the reporter, staff were being trained how to load the lenses properly into the inserter when the haptic damage occurred while loading.There were no other procedural complications.In the surgeon¿s opinion, the likely cause of the event was improper deployment of the intraocular lens, causing trailing haptic damage.The patient¿s prognosis is good and they may require an additional lens.Though requested, no additional information has been received.

Manufacturer Narrative

The additional information received from the reporter was reviewed, and the conclusions from our original report submission remain unchanged.

Event Description

It was reported that 126 days post original surgery, an intraocular lens (iol) of the same model and different diopter was implanted successfully into the patient's left eye.The 2.75mm incision was enlarged to 2.8mm, and the iol was inserted without difficulty.The patient was reportedly stable after placement of the iol.

• 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: 9948954
• MDR Text Key: 187304391
• Report Number: 0001313525-2020-00072
• 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: 01/01/2005,07/11/2019

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 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: 07/11/2019
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT IOL AND PROVISC; SOFPORT IOL AND PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR