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

Model Number EZ-24

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

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Information (3190); No Code Available (3191)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.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 the lens haptic became kinked during intraocular lens (iol) implant surgery on the left (os) eye.The lens was removed and a vitrectomy was performed.Additional information has been requested, but has not yet been received.

Event Description

It was reported by the surgeon the intraocular lens (iol) was loaded incorrectly resulting in a kinked haptic.The procedure was complicated by a broken capsule.The orientation of the lens did not change and the optic was free and clear of imperfections.The patient did not notice a decrease in vision.In the surgeon''s opinion, the likely cause of the event was a kinked haptic and the patient''s prognosis is excellent.

Manufacturer Narrative

The conclusions from our previous report submission remain unchanged.

Manufacturer Narrative

The conclusions from our original report submission remain unchanged.

Event Description

It was reported the surgeon did not recall if there was any capsule damage or loss of vitreous, but no vitrectomy was performed.The iol damage was noticed after implantation and the lens was removed intraopertively and replaced with another lens of the same model and diopter.The surgeon had no product quality concerns.In his opinion, the most likely cause of the damage was related to the incorrect loading which probably caused the leading haptic to get stuck in the injector and kinked it.Current patient prognosis is she is doing fine.

• 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: 9476451
• MDR Text Key: 182724437
• Report Number: 0001313525-2019-00207
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/27/2019

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-24
• Device Catalogue Number: EZ-24
• 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: 11/27/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/21/2020
• Supplement Dates FDA Received: 01/17/2020; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LI61AOR SOFPORT INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR