MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADAPTAO INTRAOCULAR LENS

Model Number ADAPTAOP

Device Problems Material Integrity Problem (2978); Optical Problem (3001)

Patient Problems Visual Impairment (2138); Loss of Vision (2139); No Code Available (3191)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

The lens has not been returned for evaluation.Photos provided of the lens while still inside the patient¿s eye have been reviewed and the reported product concern has been confirmed.There have been no similar events reported for this lot to date.According to the product quality engineer, it is possible that too much pressure was inadvertently applied to the lathe while it was running.The lathes are very sensitive to vibration and application of pressure may result in lathe lines.Therefore the most probable root cause is manufacturing.A nonconformance has been created for this event.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that during the implant of an intraocular lens (iol), the surgical duration was increased.The reason for this is unknown.Approximately 4.5 months post-implant damage and rings were observed on the surface of the iol with the patient reporting a loss of vision.The iol was explanted and replaced with a lens of the same model and diopter.Though requested, no additional information has been received.

Manufacturer Narrative

Photo's provided of the lens while still inside the patient's eye have been reviewed and the reported product concern has been confirmed.The iol was returned and visual inspection found that the optic was torn.Microscopic examination was performed and found that concentric rings were visible on the optic.Additional investigation identified several factors that could have resulted in lathe lines (lathe tool marks) on the iol.However, the root cause of the lathe marks could not be conclusively identified.The identified possible root causes are related to monitoring of the lathes while work is in process and correct use of the reticle during the cosmetic inspection process.A nonconformance was created for this event.As these require employee action, training was developed to address the issues and the training was provided to all lathing operators and cosmetic inspectors.There have been no similar events reported for this lot to date.A review of the device history record found no nonconformities or anomalies related to this complaint.There is no indication that any additional product is impacted.The history review performed for the nonconformance indicated that for the last five years, a failure to detect lathe lines during cosmetic inspection occured approximately once in every 911,000 lenses.Due to the low frequency, no product action (hold or recall) was deemed necessary.No further corrective action is necessary at this time.The investigation is complete.

Event Description

Additional information was received, indicating the original surgery on the patient¿s left eye was not complicated in any way.Approximately (b)(6) months post-implant, narrow rings were observed on the surface of iol.With the patient reporting a decrease in their vision.

Manufacturer Narrative

The lens was not returned for investigation.As previously reported, this is an isolated manufacturing event.A non-conformance was initiated and corrective actions and risk assessment activities have been put in place.No further actions necessary at this time.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11015006
• MDR Text Key: 221724675
• Report Number: 0001313525-2020-00198
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P060022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: ADAPTAOP
• Device Catalogue Number: ADAPTAOP0000
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR