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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided, best estimate is between (b)(6) 2019 - (b)(6) 2020.(b)(4).Product evaluation was not performed because per the initial report the lens was discarded.The complaint issue reported could not be verified and no product deficiency could be identified.The manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Note: the device was manufactured at the kulim 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 that an intraocular lens (iol) was explanted due to a surprise outcome.Replacement iol was a zxt300, 18.5 diopter power.There was no complications or patient harm.Explanted iol not saved.No other information was provided.
Additional Manufacturer Narrative
Additional information: further follow-up response received that patient had blurred vision.Post photorefractive keratotomy (prk) patient years ago.Date of event confirmed to be on (b)(6) 2019.The following sections have been updated: section b3: date of event: (b)(6) 2019.Section h6: patient code: 2137.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 (b)(4) and (b)(4).

• 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: 9927465
• Report Number: 2020664-2020-00027
• Device Sequence Number: 2828111
• Product Code: HQL
• UDI-Device Identifier: 05050474553255
• UDI-Public: (01)05050474553255(17)210723
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 12/29/2020
• 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: 07/23/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 10/25/2020; 12/03/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 10/30/2020; 12/30/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005