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

Model Number EZ-28V

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

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

The device 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.Based on the information provided, we are unable to determine root cause.No corrective action is necessary at this time.

Event Description

It was reported that during insertion of an intraocular lens (iol) into the left eye, the lens was not able to be placed due to rupture of the posterior capsule.The lens was removed with forceps and a vitrectomy was performed.The iol optic was clear and free of debris/deposits.An anterior chamber lens was successfully placed.No sutures were required as a result of the change in surgery plan.The surgeon does not know what caused the posterior capsule tear.The patient¿s prognosis is good.

• 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
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 9722589
• MDR Text Key: 183916247
• Report Number: 0001313525-2020-00037
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,12/18/2019

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 Catalogue Number: EZ-28V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 01/30/2020
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR