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); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.If explanted, give date: not applicable, as the lens remains implanted.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 13.0 diopter intraocular lens (iol) was implanted in the patient''s left eye (os) on (b)(6) 2017.Post-operatively, the patient complaint of day and nighttime starbursts and halos, which has made it dangerous to drive.The patient also complaint of glare, especially when driving.Reportedly, the patient has to wear cheaters to perform up-close work and states he has dry eye, but is taking over the counter medication for this.The patient also had a lasik consultation, which he was advised would not help with the current issue.The patient will be meeting with the surgeon on (b)(6) 2018 to discuss options of having the lens exchanged.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient''s left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
This supplemental report pertains to os, left eye.Additional information received reports that the lens is planned for explant.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.A search revealed that no similar complaints were received from this production order.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: based on the investigation results 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 supplemental report pertains to os (left eye); if explanted, give date; (b)(6) 2018.Per new information received, os lens was explanted and implanted with sa60wf 13.0 lens.Reportedly, patient continues to experience starburst with some type of lights, but less than the previous lens.It was noted that distant vision is the same as the previous lens.Patient's vision when reading the computer screen is perfect and uses cheaters for reading very small print.Patient had no issues with driving.Patient's follow-up appointment will be on (b)(6) 2018 possibly to remove stitch.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.; santa ana CA 92705
• MDR Report Key: 7338623
• Report Number: 9614546-2018-00252
• Device Sequence Number: 16554524
• Product Code: MFK
• UDI-Device Identifier: 05050474560536
• UDI-Public: (01)05050474560536(17)190501
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

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: Physician
• Device Expiration Date: 05/01/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/28/2018; 05/07/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/25/2018; 06/05/2018
• 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: Other