MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS SINGLE USE INSERTION DEVICE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number AI-28

Device Problems Device Handling Problem (3265); Failure to Eject (4010)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the product is not available for return.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There are no open non-conformances for this complaint type.There have been no other complaints for this lot number.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 an intraocular lens (iol) became stuck inside the delivery device while either partially or completely inside the patient¿s eye.The lens and delivery device were removed from the eye.There was no incision enlargement, but sutures were necessary which were not part of standard protocol.The capsular bag was not damaged.There was no loss of vitreous and no vitrectomy was performed.A backup lens of a different model and diopter was successfully implanted.In the physician's opinion, the likely cause of the event is that the lens was stuck in the delivery device.The patient has no complaints and a positive prognosis and treatment.Though requested, no additional information has been provided.

• Brand Name: AKREOS SINGLE USE INSERTION DEVICE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 9444612
• MDR Text Key: 174301462
• Report Number: 0001313525-2019-00201
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/01/2005,11/13/2019

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: 07/08/2020
• Device Model Number: AI-28
• Device Lot Number: H958201
• 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: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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