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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that while attempting to insert an ar40e, 13.0 diopter intraocular lens (iol) into the patient¿s right eye, it was noted to have a bent/broken haptic.There was patient contact however the iol did not remain implanted.The incision was enlarged, and the damaged iol was removed from the eye.The patient recovered, and the outcome does not interfere with the patient¿s daily life.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, yes.Returned to manufacturer on, (b)(6) 2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The iol was received inside the lens case.The lens was observed with one haptic positioned but bent and cut and the other detached and missing.The optic edge was observed cut.The complaint was verified however due the condition of the lens received the cause of the complaint is undetermined.A product quality deficiency was not identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: 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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9414671
• Report Number: 2648035-2019-01285
• Device Sequence Number: 2424400
• Product Code: HQL
• UDI-Device Identifier: 05050474501966
• UDI-Public: (01)05050474501966(17)230424
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 10/25/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/31/2019; 11/05/2020
• 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: 35 YR
• Date Report Sent to FDA: 01/01/2005