MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number AO60P

Device Problems Calcified (1077); Material Opacification (1426)

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

One iol was returned in an unknown small plastic vial.As the original packaging was not returned, the part number and serial number cannot be verified.However, the lens does have the appearance of the reported lens.Particulates were visible on the lens.Visual inspection found the lens optic had been cut or torn in half.One haptic is attached to each piece of the optic.Two haptics have been torn off and were not returned.Microscopic examination found that the optic had a cloudy white appearance and some areas with an orange peel appearance.The lens has been submitted for laboratory analysis.The device history record was reviewed and there are no anomalies or nonconformances that may be related to this event.This investigation is ongoing.

Event Description

It was reported that an intraocular lens (iol) was explanted from a patient¿s right eye fourteen months post implant due to residue on the lens.The original implant procedure was uncomplicated.The orientation of the lens did not change.The patient reported a film over their vision did not improve with blinking and would not resolve.The lens was explanted and replaced with a lens of a different model and diopter, using irrigation and aspiration.The surgeon described an abnormal film on the anterior surface of the lens.The patient¿s outcome is good.

Manufacturer Narrative

A laboratory investigation was performed in an attempt to determine the root cause of the opacification.Through optical inspection, laser confocal microscopy, scanning electron microscopy, and electron dispersive xray spectroscopy, it was determined that the opacification was due to the presence of round deposits on the posterior iol surface comprised primarily of calcium and phosphorous.These findings are consistent with historical of the reported lens, opacification lens returns.The opacification of the lens investigated herein from the complaint can best be described as due to calcification.Per publications there are three major types of calcification have been identified.The primary form refers to calcification is caused by factors inherent to the iol design or material.The secondary form refers to deposition of calcium onto the surface of the iol caused by environmental factors (e.G.Changes in the aqueous surrounding the implanted iol associated with pre-existing or concurrent diseases, or due to additional surgical intervention).It is not related to any problem with the iol itself.Finally, the third form is a false-positive or pseudo-calcification in which other pathology is mistaken for calcification or false-positive staining for calcium occurs.Various mechanisms explaining the formation of mineral deposits have been suggested.The underlying pathogenetic mechanisms of delayed postoperative calcification remains unknown and a broad spectrum of biological, pharmacological, technological, and/or certain topical environmental factors may be involved.The product evaluation confirmed the failure mode.There have been no other complaints for this lot to date.It is noted that the inserter used to deliver the lens is not validated for use with this lens.The lot history, 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 that calcification of the iol is a known procedure complication.No corrective action is necessary at this time.

• Brand Name: AKREOS INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 10373262
• MDR Text Key: 204358606
• Report Number: 0001313525-2020-00101
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/09/2020

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: 12/31/2019
• Device Model Number: AO60P
• Device Catalogue Number: AO60P1950
• Device Lot Number: 1742004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• 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: 07/09/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EZ-28V INSERTER, OCUCOAT VISCO, BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR