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

Model Number	ZCT225
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
Additional information: gender/sex: unknown, information not provided.Date of event: exact date unknown, information not provided.Best estimate is between (b)(6) 2019- (b)(6) 2020.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.Note: the device was manufactured at the (b)(4) site which has been closed.All pertinent information available to (b)(4) surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was replaced in a different procedure, therefore explanted.Reason for explant was not provided.The lens was replaced with model zcu225 19.0 diopter iol.There was no other surgical intervention such as incision enlargement or vitrectomy.No further information was provided.
Additional Manufacturer Narrative
Additional information: device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.Conclusion: based on the investigation, no product quality deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation: yes, returned to manufacturer on 5/18/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received inside a specimen cup.Additional documentation was received as well.Visual inspection under magnification revealed viscoelastic residue and what appeared to be dried blood on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the returned condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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: 10014940
• Report Number: 2020664-2020-00031
• Device Sequence Number: 11501342
• Product Code: HQL
• UDI-Device Identifier: 05050474552821
• UDI-Public: (01)05050474552821(17)220530
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 10/30/2020
• 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: 05/30/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 05/21/2020; 10/25/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/07/2020; 05/21/2020; 10/30/2020
• 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
• Date Report Sent to FDA: 01/01/2005