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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - exact date is unknown, symptoms were first reported by the patient 2.5 weeks post implant therefore, (b)(6) 2018 is being provided as a best estimate.(b)(4).It was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zkb00 25.5 diopter intraocular lens (iol) was explanted from the patient¿s right eye (od) due to issues with glare and visual disturbance.Through follow-up it was learned the patient first reported blurred distance vision and near when reading two and half weeks after implantation.The lens was subsequently explanted requiring the incision to be enlarged from 2.4 mm to 2.8mm.The replacement lens was the same model but a lower diopter (23.5).The explanted lens was discarded and is not available for evaluation.The patient was noted to be recovered and the outcome does not interfere with activities of daily life.No additional information provided.

• 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: 7481997
• Report Number: 9614546-2018-00419
• Device Sequence Number: 13536675
• Product Code: MFK
• UDI-Device Identifier: 05050474560192
• UDI-Public: (01)05050474560192(17)200205
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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: 02/05/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/02/2018
• 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: Required Intervention