MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Injury (2348); No Code Available (3191)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
: date of event: unknown, not provided, but the best estimate date is during (b)(6) 2020- (b)(6) 2020.Patient code (b)(4).Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from patient left eye.Iol was replaced with same model lens but lower diopter power.No further information is provided.
Additional Manufacturer Narrative
Per follow-up communication.Lens was explanted, due to unexpected outcome with refractive error, power discrepancy, history of (h/o) prior refractive surgery.Blurred vision, patient was myopic at day (b)(6) post-op.Based on the additional information provided, the following fields have been updated: section b3: date of event: (b)(6) 2020; section h6: patient code updated 2137, blurry vision; section h6: patient code updated 2138, unexpected postop refraction.Device evaluation: product evaluation was not performed, because the product has not yet been received.The complaint issue reported could not be verified.And no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed, that no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.And the reported issue could not be verified.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11009141
• Report Number: 2020664-2020-00058
• Device Sequence Number: 4563449
• Product Code: MFK
• UDI-Device Identifier: 05050474535749
• UDI-Public: (01)05050474535749(17)220705
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 07/05/2022
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: 61 YR