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

Model Number	Z9002
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
Age/date of birth: unknown/ not provided.Date of event: exact date is unknown, best estimate is between 2/16/2016 - 9/2/2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to unexpected post-op refraction.This was replaced with model za9003 23.5 diopter lens.The patient has recovered post-op.No other information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation?: yes.Returned to manufacturer on: 10/21/2020.Section h3.Device returned to manufacturer?: yes.Device evaluation: the complaint lens was received in the replacement lens¿ lens case.The replacement lens'' folding carton was received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic, and that the lens was received cut in half, which is consistent with a lens handled during explant.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 record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one other complaint was received from this production order, but is not related to this complaint.Furthermore, this complaint meets the criteria for no further investigation per johnson & johnson surgical vision complaint handling procedures, therefore, the complaint issues could not be confirmed, no product deficiency could be identified and no escalations are required.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: TECNIS CL
• 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: 10731460
• Report Number: 2648035-2020-00775
• Device Sequence Number: 1114989
• Product Code: HQL
• UDI-Device Identifier: 05050474530751
• UDI-Public: (01)05050474530751(17)201117
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 11/17/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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