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

Model Number AI-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the device was discarded and is not available for evaluation.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this 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 contributed to the event.

Event Description

The user facility in (b)(6) reported an intraocular lens (iol) implantation failure during surgery.On delivery to the capsular bag, the lens became stuck in the delivery device.The surgeon pulled the plunger back and then inserted the lens.It was noted the lens was torn with one half in the capsular bag and the other half remaining in the insertion device.The incision was enlarged to remove the iol and replaced with an unknown model and diopter lens.Surgery time was extended approximately 5 minutes and a suture was required.The patient¿s visual acuity did not change and the prognosis is good.

• Brand Name: AKREOS SINGLE USE INSERTION DEVICE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB INC; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 11313572
• MDR Text Key: 231366466
• Report Number: 0001313525-2021-00020
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K063694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

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: AI-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• 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
• Treatment: AKREOS ADAPTAO INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention