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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2019-(b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct400 22.0 diopter intraocular lens (iol) was explanted from the patient's right eye due to the patient having 2 diopters of residual cylinder.Target refraction -0.18, post-op refraction -1.50 2.00 x 126, uncorrected visual acuity (ucva) 20/40, best corrected visual acuity (bcva) 20/25, lens location eight degrees.Through follow-up, it was learned that the lens was replaced with a different model lens zcu300 with a 22.0 diopter.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly.Device available for evaluation, returned to manufacturer on: 3/17/2020.Device evaluation: the lens returned cut in half into a specimen container.The condition observed is consistent with a lens that has been cut due to ¿iol removal or explant¿ surgical process.Visual inspection using magnification was performed.Both lens haptics were observed in good shape.The diopter measurement could not be performed due to the condition of the lens returned (cut).There is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.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 other complaints for this production order number have been received.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.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 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: 9900511
• Report Number: 2648035-2020-00296
• Device Sequence Number: 18996191
• Product Code: HQL
• UDI-Device Identifier: 05050474553958
• UDI-Public: (01)05050474553958(17)230223
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 11/02/2020
• 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: 02/23/2023
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 10/25/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/10/2020; 11/02/2020
• 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