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	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that lens model, zlb00 multifocal iol (intraocular lens) was explanted from patient's left eye (os) due to dissatisfaction.It was also noted that there was a incision enlargement, but there was no patient injury.No additional information provided.
Additional Manufacturer Narrative
Corrected information: the following information was known at the time of the initial report but inadvertently was not included; therefore, it is captured in this supplemental report: through follow up, it was learned that refractive error was not the reason for the explant and the patient did not have blurry vision or any other visual acuity issues.The patient just did not like the design of the multifocal lens.There was no suture or vitrectomy enquired and reportedly, the patient was stable at the time of discharge.Additional information: device available for evaluation: yes.Returned to manufacturer on: 3/7/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site inside of a plastic re-sealable bag, the lens was wrapped into medical dressing.The product was visually inspected with the unaided eye showing the lens was whole and intact.The lens was cleaned and dried, the visual inspection proceeded with magnification and revealed no obvious damage.The complaint was not confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.There were no non conformance's with respect to the manufacturing process.The product was manufactured and released according to specifications.A search on complaints related to this production order was conducted in the complaint system.The search revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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: 8428988
• Report Number: 3011852734-2019-00061
• Device Sequence Number: 11510492
• Product Code: MFK
• UDI-Device Identifier: 05050474560666
• UDI-Public: (01)05050474560666(17)220712
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 07/12/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/24/2019; 10/25/2020
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/19/2019; 11/11/2020
• 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
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005