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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, not provided, only month and year, (b)(6) 2020.(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 aab00 intraocular lens(iol) was explanted from patient's right eye in a secondary surgical procedure because of refractive error.The patient was doing fine at the time of discharge.Additional information was received stating that an incision enlargement was required to remove the lens from patient's eye.There were no sutures or vitrectomy required.There was no issue with the lens and no patient injury.The patient does not have any pre-existing medical conditions related to the eye.The replacement lens is a same model but lower diopter, 18.5.No further information provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes section d10: returned to manufacturer on: 12/10/2020 section h3: device returned to manufacturer: yes device evaluation: the complaint lens was received in the replacement iol¿s lens case inside a specimen cup with a different serial number¿s patient sticker.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic, which is consistent with a lens that was handled during explant.The lens was cleaned, and lens damage was observed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed no additional complaint was received from this production order.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.

• 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: 10865197
• Report Number: 2648035-2020-00871
• Device Sequence Number: 2521627
• Product Code: HQL
• UDI-Device Identifier: 05050474548671
• UDI-Public: (01)05050474548671(17)240622
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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