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

Model Number	ZCT450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/16/2020
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).Device evaluation: on february 28, 2020 the lens was received in a sealed pouch provided by the customer, in addition a biohazard bag.Visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Additionally, viscoelastic residue was observed on the optic body and haptics.The lens was cleaned, and no cosmetic defects were observed on both haptics.Based on the condition of the return lens no further product evaluation (visual inspection of optic body) could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed in the results revealed no other complaints have been received for this po number.Conclusion: based on the results of the investigation there is no indication of a product quality deficiency.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 from the patient's right eye due to a mechanical complication.Further information was provided and it was learned that the reported mechanical complication was in reference to the patient having previous lasik, and when the patient got the lens implanted it threw her numbers off.The patient became near sighted.There was nothing wrong with the lens.At explant there was no vitrectomy, incision enlargement or sutures required.There was no patient injury.A model zct150 13.5 diopter lens was implanted as a replacement.The patient is doing fine upon discharge.No additional information was provided to johnson & johnson surgical vision.
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: 9809299
• Report Number: 9614546-2020-00113
• Device Sequence Number: 2891338
• Product Code: HQL
• UDI-Device Identifier: 05050474602847
• UDI-Public: (01)05050474602847(17)210212
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 02/12/2021
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 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
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005