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

Model Number	ZCT400
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2019.(b)(4).Attempts have 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 zct400 intraocular lens (iol) 19.0 diopter was removed due to refraction being off.This was replaced with a zct400, 14.0 diopter power.Follow-up confirmed that the patient is well post-op.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that in the initial mdr submitted: device code and patient code were inadvertently not populated.This supplemental submission is to add the codes in those respective sections.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 9/12/2019.Device evaluated by manufacturer? yes.Device evaluation: on september 12, 2019 a lens box was received but without an iol.The lens box only contained an empty daisywheel.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.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.
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
• 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: 8926603
• Report Number: 9614546-2019-00770
• Device Sequence Number: 2128450
• Product Code: HQL
• UDI-Device Identifier: 05050474553897
• UDI-Public: (01)05050474553897(17)220205
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 11/10/2020
• 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: 02/05/2022
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 09/17/2019; 10/25/2020
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/18/2019; 10/10/2019; 11/11/2020
• 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