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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); No Code Available (3191)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Customer reported an intraocular lens (iol) was explanted.The reason for explant was not provided.Reportedly there was no vitrectomy, sutures or incision enlargement.The explanted lens was replaced with a non-johnson and johnson iol.The patient outcome is fine.Per the customer, no further information is available.
Additional Manufacturer Narrative
Correction: this is to correct follow-up #1 for mdr# 9614546-2020-00529.It did not include the additional information received which stated the patient's symptoms were blurry vision and halos.Therefore, the following correction applies.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the incorrect manufacturing site was inadvertently entered in initial emdr, section g.The correct address is anasco industrial park, road 402 north, km 4.2, anasco, ud, 00610.Therefore, the mfr report number in section g9 should begin with 2648035.Additional information: section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/6/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was returned cut in half with lens damage, 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 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.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.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: 11052776
• Report Number: 9614546-2020-00529
• Device Sequence Number: 14116257
• Product Code: MFK
• UDI-Device Identifier: 05050474560109
• UDI-Public: (01)05050474560109(17)240620
• 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: 2020
• 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): 02/24/2021

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: 06/20/2024
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 02/22/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/24/2021
• 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
• Patient Age: 73 YR