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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	10/22/2020
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 that a model ar40e intraocular lens (iol) was partially inserted into the patient's right eye and then removed due to a broken haptic inside the eye.A vitrectomy, sutures, and incision enlargement were required.No patient injury was reported.The replacement lens is the same lens model and diopter.No further information is available.
Additional Manufacturer Narrative
Device available for evaluation? yes returned to manufacturer on: 1/6/2021 device returned to manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and remaining haptic and that the lens was returned cut (but not separated), which is consistent with a lens that was handled during removal and replacement.Furthermore, a detached haptic (not returned) and a damaged haptic with missing material were observed.Dimensional inspection could not be performed because returned haptic was damaged, the other haptic was detached, and the drill hole was returned with a customer handled lens.¿dc-haptic damaged¿ was confirmed, however per the initial report the ¿broken haptic¿ was observed during handling for insertion, and therefore cannot be confirmed to be related to manufacturing and no product deficiency could be 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 complaints 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.

• 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: 11061670
• Report Number: 2648035-2020-00957
• Device Sequence Number: 11409405
• Product Code: HQL
• UDI-Device Identifier: 05050474502055
• UDI-Public: (01)05050474502055(17)240301
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/24/2021

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: 03/01/2024
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL NOT PROVIDED; CARTRIDGE MODEL NOT PROVIDED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR