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	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is between (b)(6) 2019 and (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient has bilateral implants; however, he has been able to see well in his right eye following surgery but not in his left eye despite refraction.Retinal scans appeared to be normal, however the patient could not read clearly, and his distance is blurry as well.There is no easily identifiable factor contributing to this.Reportedly, a zlb00 21.5 diopter intraocular lens (iol) was implanted in the patient's left (os) eye on (b)(6) 2019.It was later explanted on (b)(6) 2019 and replaced with another zlb00 with a higher 22.5 diopter.No further information was provided.
Additional Manufacturer Narrative
Based on receiving new information, the following field has been updated accordingly.Date of event: (b)(6) 2019.Patient is happy with improved vision to 20/25 uncorrected and improved reading.Device available for evaluation: yes.Returned to manufacturer on: 6/4/2019.Device returned to manufacturer: yes.Device evaluation: the lens was received within a resealable plastic bag stuck to a paper towel.The lens was observed to be cut in half, most probably to ease in explant.Upon removal from the paper towel, paper fibers remained stuck on the lens.Based on the condition of the return, further analysis is not possible.The reported issue could not be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be 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: 8676036
• Report Number: 3011852734-2019-00119
• Device Sequence Number: 2372184
• Product Code: POE
• UDI-Device Identifier: 05050474560703
• UDI-Public: (01)05050474560703(17)210710
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 07/10/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 10/25/2020
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/19/2019; 11/12/2020
• 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: 81 YR
• Date Report Sent to FDA: 01/01/2005