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); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2019-(b)(6) 2019.If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site as the lens remains implanted; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.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.
Event or Problem Description
It was reported that the patient is unhappy with her lens in her left eye as her vision is fuzzy and she cannot read close up or see distance vision because of the blurriness.The lens was implanted in (b)(6) 2019, around one week post-operative the patient started noticing the impaired vision, and shortly after her implant, the surgeon conducted a yttrium aluminum garnet (yag) procedure.The patient was still dissatisfied.The patient was then referred to a retina specialist and later a cornea specialist.Both specialist's told the patient her retina and cornea were fine.The patient is not happy she still has to use readers or glasses.At this time, the lens remains implanted.No additional information was provided.
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: 10269001
• Report Number: 9614546-2020-00248
• Device Sequence Number: 16344478
• Product Code: MFK
• UDI-Device Identifier: 05050474560093
• UDI-Public: (01)05050474560093(17)191130
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• 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: 11/30/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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