MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number	AAB00
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Zonular Dehiscence (2698); No Code Available (3191)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that intraocular lens was removed and replaced from patient¿s operative eye in the same surgical procedure because of patient¿s large zonular dehiscence due to which lens was tilted.During the procedure incision was enlarged.Additional information was received and it was learnt that there was no issue with the lens but there was anatomical issue with the patient.Patient had a loose zonules due to which after the lens was implanted doctor observed that lens was not secure and had positioning issue so the lens was removed and replaced.Customer confirmed that there was no patient injury.Patient is doing good.No further information.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 07/23/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under 12x microscope magnification was performed and showed no abnormalities found on the returned lens.Lens was further measured and all measurements (haptic width, optic diameter, overall diameter and haptic thickness) were within specification.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7674896
• Report Number: 3011852734-2018-00121
• Device Sequence Number: 13821768
• Product Code: HQL
• UDI-Device Identifier: 05050474548756
• UDI-Public: (01)05050474548756(17)210523
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 10/25/2020
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/27/2018; 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005