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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted: not applicable, as the intraocular lens was inserted and removed in the initial surgery.If explanted: not applicable, as the intraocular lens was inserted and removed 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 intraocular lens (iol) was fully inserted in the patient¿s operative eye and removed due to broken haptic.The incision was enlarged and there was no patient injury.Another lens with the same model was implanted.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 09/10/2020.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint product was returned in its packaging and inside the daisy wheel case insert.Visual inspection performed under microscope: lubricating material residue and loose particle can be observed on the lens surface.The lens was cut and only a piece of lens was returned.This could be related to the removal process.One of the haptic was broken and the other looks damaged/distorted.Therefore, the reported issue was verified however, due to the conditions of the sample returned it is not possible to determine if the reported issue is related to the manufacturing process or to the handling during the removal process.Based in the analysis of the sample returned product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 10541340
• Report Number: 2648035-2020-00685
• Device Sequence Number: 14255287
• Product Code: HQL
• UDI-Device Identifier: 05050474514201
• UDI-Public: (01)05050474514201(17)230418
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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
• Report Date (Section B): 10/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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: 51 YR