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

Model Number	ZLB00
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Note: the device was manufactured at the (b)(4) 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 a model zlb00 22.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2019.The zlb00 lens was explanted on (b)(6) 2020 due to initial complaint of blurred vision from the patient.The surgeon noticed lathe marks on the lens with slit lamp, refraction was +.50 -.25.At a later follow-up the patient complained of foreign body sensation in the eye, and strobe light effect at night, refraction +.50.The zlb00 lens was explanted and replaced with a model zlb00 22.5 diopter iol.There was no patient consequence or wound enlargement, no vitrectomy, and the patient was stable when leaving surgery center.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 02/12/2020.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received submerged in an unknown liquid in a specimen cup, in addition to a biohazard bag.Visual inspection under magnification revealed that the lens was received cut in half and only one half was received, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 9689564
• Report Number: 2020664-2020-00011
• Device Sequence Number: 3319452
• Product Code: MFK
• UDI-Device Identifier: 05050474560727
• UDI-Public: (01)05050474560727(17)210528
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 10/25/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/17/2020; 11/03/2020
• 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: 58 YR
• Date Report Sent to FDA: 01/01/2005