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

Model Number AI-28

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The inserter is not available for investigation as it was discarded by the user facility.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 a patient had an intraocular lens (iol) implanted and a crack was noted by the surgeon at the optic/haptic junction.The lens was removed and replaced with a new lens intraoperatively.The original and replacement lens are the same model and power.The wound was enlarged to remove the iol.Additional information has been requested but has not been received.

• 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 n park pl blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 9489477
• MDR Text Key: 178563740
• Report Number: 0001313525-2019-00209
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,11/05/2019

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: AI-28
• 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: 12/03/2019
• Initial Date FDA Received: 12/18/2019
• 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