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 Code	Capsular Bag Tear (2639)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had an hole in the capsule of eye.Event was observed when inserting into the eye.No further information is available.
Additional Manufacturer Narrative
Additional information from follow-up were received indicating the lens was removed and replaced from the patient''s left eye within the initial surgery.The replacement lens is a model za9003 13.5 diopter lens, and the date of event was provided.Additionally, the surgeon's name was provided, patient gender, and date of birth.Therefore, the following sections are updated accordingly, section a2: (b)(6) 1965.Male.Date of event: (b)(6) 2020.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Device available for evaluation ¿ yes, returned to manufacturer on 10/12/2020.Device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was received in its original lens case.The original folding carton, patient stickers, patient id card, and directions for use (dfu) were received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received almost cut in half (but not separated), which is consistent with a lens handled during removal.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints have been received for this po number.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: 10668672
• Report Number: 2648035-2020-00754
• Device Sequence Number: 14079473
• Product Code: HQL
• UDI-Device Identifier: 05050474548534
• UDI-Public: (01)05050474548534(17)240209
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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: Other
• Patient Age: 55 YR