MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age/date of birth: unknown as information was not provided.(b)(4).Attempts were made to contact the customer account requesting additional information regarding complaint 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 intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).The iol was explanted and replaced with a different lens model (zxr00) and different diopter size (14.0).No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.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.
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: (b)(6) 2021.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received stuck to a card with customer notes.Additional documentation was received as well, which included scans of the complaint lens¿ patient sticker and the replacement lens¿ patient sticker.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was returned cut in half (but not separated), which is consistent with a lens that was handled during explant.Furthermore, fibers were observed on the lens, however this can be attributed to receiving the lens stuck to a card and therefore cannot be confirmed to be related to manufacturing.Based on the return condition of the lens and because the customer has not specified the complaint issue, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.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: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10654176
• Report Number: 9614546-2020-00447
• Device Sequence Number: 3146002
• Product Code: MFK
• UDI-Device Identifier: 05050474560567
• UDI-Public: (01)05050474560567(17)230418
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 04/18/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 01/22/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/09/2020; 02/09/2021
• 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