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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Patient Involvement (2645)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.If implanted; give date: not applicable as lens was removed/replaced in the initial procedure.If explanted; give date: not applicable as lens was removed/replaced in the initial procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was removed/replaced as a vitrectomy was required.The lens was replaced with an anterior chamber lens.Patient outcome was reported as fine.No further information was provided.
Additional Manufacturer Narrative
Additional information/corrected data: additional information was received and it was learned that there was no patient involvement with this lens.Reportedly an anterior chamber was implanted instead for the patient.Therefore this complaint is no longer considered a reportable event.Hence no further information will be provided under report number 2648035-2019-00435.Patient code provided in the initial report is now updated (b)(4).Device available for evaluation; returned to manufacturer on: 4/15/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed torn.The lens condition is typically of a removed or explanted lens.According to the initial report there is no complaint against the lens.A product quality deficiency was not identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints related to this production order was conducted in the complaint system.The search 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 for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 8490230
• Report Number: 2648035-2019-00435
• Device Sequence Number: 19336660
• Product Code: HQL
• UDI-Device Identifier: 05050474514195
• UDI-Public: (01)05050474514195(17)190322
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 03/22/2019
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 10/25/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/07/2019; 11/11/2020
• 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
• Date Report Sent to FDA: 01/01/2005