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	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (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 an intraocular lens (iol) was explanted from the patient¿s left eye due to visual disturbance.The lens was cut and removed from the eye without incision enlargement.No vitrectomy or sutures were required.There was no patient post-op injury.No other information was provided.
Additional Manufacturer Narrative
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 (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 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 record review: the manufacturing process record was evaluated and revealed, that there was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed, that no other complaints were received from this production order.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 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: 11092710
• Report Number: 2648035-2020-00973
• Device Sequence Number: 10971904
• Product Code: MFK
• UDI-Device Identifier: 05050474560741
• UDI-Public: (01)05050474560741(17)240129
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• 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: 01/29/2024
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 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