MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).Device evaluation: visual inspection using magnification was performed to the returned sample.This revealed loose fibers/particles observed on lens related the handling of the unit out of a sterile environment.Residues of viscoelastic material were observed on lens.A depression mark was observed on the lens surface.One of the haptic was observed damaged/distorted.No damaged was also observed to the other haptic.The condition in which the sample returned is consistent with a lens that was implanted and removed.There was no quality issue reported against the lens.Based on the analysis of the returned sample, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed that no additional investigation requests were received for this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002, 18.5 diopter intraocular lens (iol), during surgical examination, the lens did not position correctly due to patient's anatomy.An anterior vitrectomy was performed, and a non-johnson & johnson surgical vision lens was placed successfully.Additional information was received, and it was learnt that there was an incision enlargement required and sutures were placed.But no patient post-op injury.It was noted that there was no product quality issue.No other information 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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8559547
• Report Number: 2648035-2019-00495
• Device Sequence Number: 2168598
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)220216
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020
• 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: 02/16/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/27/2019
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005