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 Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event, date of onset is unknown/not provided.Best estimate is between (b)(6) 2019 - (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 tecnis multifocal intraocular lens (iol) was explanted from the patient's right (od) eye due to wrong power.There was no additional surgical intervention performed during the secondary procedure.The replacement lens is a same model, but a higher diopter (24.0).Reportedly, the patient is doing good post-operative.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not yet been received.Per external communications, the customer confirmed they sent the product back using their own shipping label.If product is received after initial closure, the investigation request (ir) and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.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 of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 1/26/2021.Section h3: device returned to manufacturer: yes.Device evaluation: the product was received wrapped in gauze.A different serial number''s patient stickers and additional documentation were received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was returned cut in half, which is consistent with a lens that was removed (despite the initial report not mentioning lens removal).Furthermore, fibers were observed stuck to the lens, however this can be attributed to the lens being returned wrapped in gauze, and therefore cannot be confirmed to be related to manufacturing.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.Conclusion: as a result of the investigation there is no indication of a quality product 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 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: 10633193
• Report Number: 2648035-2020-00739
• Device Sequence Number: 2555284
• Product Code: MFK
• UDI-Device Identifier: 05050474560727
• UDI-Public: (01)05050474560727(17)221016
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 02/19/2021

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: 10/16/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 02/19/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/06/2020; 02/19/2021
• 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