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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.Date of event: exact date of event unknown/not provided.Best estimate is between 8/29/2019 ¿ 01/19/2020.(b)(4).Note: the device was manufactured at the kulim site which has been closed.Attempts were made to contact the customer account requesting additional information 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 zlb00 20.0 diopter intraocular lens (iol) was implanted in the patient's ocular sinister (left eye) on (b)(6) 2019.The zlb00 20.0 diopter lens explanted from the patient¿s operative eye on (b)(6) 2020 and replaced with another zlb00 lens.Attempts were made to obtain additional information, however, to date no response has been received.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: through follow-up additional information was received, the patient did not like the lens, experienced blurred vision, was bothered by dysphotopsia, therefore the lens was explanted.The patient's visual acuity pre-op was 20/40, visual acuity post-op 20/60.At explant there was no incision enlargement, vitrectomy, or sutures required.As a result of the additional information provided the following patient codes have been added: 2140, 2138, 2137.Section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 03/12/2020.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the lens was received inside a non-jnj cartridge tray.Additionally, a completed complaint shipping guide was received.Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptic, and that the lens was received cut in half (one half of the lens missing), which is consistent with a lens that was handled during explant.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was 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 revealed that no other 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.H3 other text : placeholder.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• 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: 9709026
• Report Number: 2020664-2020-00014
• Device Sequence Number: 3474302
• Product Code: MFK
• UDI-Device Identifier: 05050474560673
• UDI-Public: (01)05050474560673(17)210716
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

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: 07/16/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 10/25/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/18/2020; 11/02/2020
• 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
• Date Report Sent to FDA: 01/01/2005