MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS

Model Number	ZCU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.Date of event: unknown as information was not provided.If implanted, give date: not applicable, as the intraocular lens was inserted and removed in the initial surgery.If explanted, give date: not applicable, as the intraocular lens was inserted and removed in the initial surgery.(b)(4).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 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.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the suspect lens was switched to a 3-pc.Lens.The suspect lens was cut out and confirmed that the incision was enlarged slightly to cut out lens.Also, an unplanned suture and vitrectomy were performed.It was learned that the suspect lens was discarded.There was no patient post-op complications.No other information was provided.
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.
Additional Manufacturer Narrative
In review of the file, it was noted that in the initial report section g, date received by manufacturer, was incorrectly entered.The following has been updated accordingly: section g-4 date received by manufacturer: correct date is 13-aug-2020 as this is the date incision enlargement, suture, and vitrectomy information was received via external communication not 06-aug-2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 09/21/2020.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in its original lens case.The original folding carton, dfu, patient id card, and implant notification were received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and that the lens was received cut in pieces (only a piece of the optic body was received), which is consistent with a lens that was handled for removal and replacement.Based on the return 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.

• Brand Name: TECNIS TORIC II 1-PIECE ACRYLIC
• 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: 10505298
• Report Number: 9614546-2020-00383
• Device Sequence Number: 2993037
• Product Code: HQL
• UDI-Device Identifier: 05050474660076
• UDI-Public: (01)05050474660076(17)250218
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 02/18/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 10/04/2020; 10/25/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/14/2020; 10/29/2020; 11/04/2020
• 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