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

Model Number	AR40M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an ar40m, 4.0 diopter intraocular lens (iol) was explanted due to a myopic miss.There was no incision enlargement, vitrectomy or sutures done.Replacement lens was another ar40m but a 5.0 diopter.It was stated that the patient was fine post-explant.It was further learnt that the suspect lens was used as a piggyback lens with a symfony toric.Pre-op best corrected visual acuity (bcva) was 20/50 and post-explant bcva was 20/40.Visual symptoms were noted on (b)(6) 2019.The toric symfony lens had rotated, was repositioned and patient is now happier.A separate report will be filed for the symfony toric lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 7/1/2019.Device evaluation: sample was received and it was cut in two pieces.Residues were observed.One haptic was observed bent and the other positioned.The complaint could not be verified since it is a patient condition.Also, per initial report the lens was used as a piggy back in where the primary lens was a model zxt.A product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaint were received from 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 (b)(4) and capa (b)(4).

• 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: 8760627
• Report Number: 2648035-2019-00684
• Device Sequence Number: 2566325
• Product Code: HQL
• UDI-Device Identifier: 05050474501782
• UDI-Public: (01)05050474501782(17)230501
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 05/01/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 10/25/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/08/2019; 11/13/2020
• 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: 45 YR
• Date Report Sent to FDA: 01/01/2005