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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Patient Involvement (2645)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.If implanted; give date: unknown as information was not provided.If explanted; give date: unknown as information was not provided.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported patient required a vitrectomy involving zct150 23.0 diopter intraocular lens (iol).No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 06/26/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a lens case.The product was disinfected according to procedure.The product was inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.No further anomalies were found.The complaint cannot be confirmed.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
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.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 similar complaints for this production order number have been received.Labeling review: the labeling review was not reviewed because limited information was 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
Corrected data: during submission of follow-up #1 report it was reported there was no patient contact and the lens was discarded.However this information was inadvertently not included in the report.Patient code was updated from 2643 to 2645 as vitrectomy is no longer applicable.Method code 4114 is now updated to 4115.With the clarification provided through follow-up, it is now known there was no patient contact with the device, this complaint is no longer considered a reportable event.No further information will be provided under report number (9614546-2019-00507).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-(b)(4) and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8661128
• Report Number: 9614546-2019-00507
• Device Sequence Number: 2663271
• Product Code: HQL
• UDI-Device Identifier: 05050474552203
• UDI-Public: (01)05050474552203(17)200904
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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,Followup,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: 09/04/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 08/08/2019; 08/08/2019; 10/25/2020
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/18/2019; 08/16/2019; 08/16/2019; 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
• Date Report Sent to FDA: 01/01/2005