MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADVANCED OPTICS IOL; INTRAOCULAR LENS

Model Number AO60P

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Information (3190); No Code Available (3191)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

Though requested, no additional information has been received from the reporter.It is unknown at what operative stage the capsule tear occurred or if the product was involved in the capsular tear.The product evaluation has been completed.One iol was returned in a plastic bio-hazard bag, wrapped in gauze, and hand-labeled with the reported product serial number.The original packaging was not returned.Particulates, saline dendrites and dried solutions were visible on the optic.Visual inspection found that the lens was in two pieces, with the optic cut or torn in half.A large section had been torn from the optic and was missing.The delivery device was not returned.The cause of the damage cannot be determined.Functional testing cannot be performed due to the damage.The investigation is ongoing.

Event Description

It was reported the patient experienced a capsular tear intraoperatively.As a result, the intraocular lens (iol) was cut out for removal.The incision was not enlarged to remove the lens and no sutures were required.Though requested, no additional information has been received.

Manufacturer Narrative

As clarified by the surgeon, no capsular tear occurred, and this event was unrelated to the device.The lens was unable to be successfully placed due to patient anatomy (questionable zonular support), resulting in a 50% inferior dehiscence.The surgeon stated that the capsular bag dehiscence was secondary to the patient¿s history of anterior vitrectomy which had resulted in weakening of the zonules.In the surgeon¿s opinion there are no product quality concerns.This event no longer meets reportability requirements.The report does not suggest the device failed to meet labeling or performance specifications.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.No other events have been reported for this product lot.The most probable root cause is that the event is patient-related.No corrective action is necessary at this time.

Event Description

Additional information has been received from the surgeon, who stated that the original information provided by the user facility is incorrect.According to the surgeon, there was no capsular tear.The patient had a prior pars plana vitrectomy years ago with questionable zonular support of the crystalline lens.During cataract surgery, the phacoemulsification was unremarkable.During the installation of viscoelastic, prior to intraocular lens (iol) insertion, the bag/zonular complex had a 50% inferior dehiscence.The surgeon was unable to stabilize the bag even with attempting to place a capsular tension ring (ctr).Due to lack of capsular support to safely put in a capsular bag or sulcus iol, the surgeon performed an anterior vitrectomy.The surgeon enlarged the wound and placed an anterior chamber (ac) iol.The wound was closed with 10-0 nylon sutures.In the surgeon¿s opinion, there are no product quality concerns.The surgeon reported that capsular bag dehiscence was secondary to anterior vitrectomy weakening zonules.The patient has recovered and is doing well.This event no longer meets reportability requirements.

• Brand Name: AKREOS ADVANCED OPTICS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 9917897
• MDR Text Key: 187449283
• Report Number: 0001313525-2020-00066
• 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: 01/01/2005,03/11/2020

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: 11/30/2022
• Device Model Number: AO60P
• Device Catalogue Number: AO60P1800
• Device Lot Number: 1974622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• 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: 03/11/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC PLUS, CTR
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR