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 Code	No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records and related documents for the production order (po) of the device were reviewed and no deviations or non- conformance reports (nc) associated to this po were found.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol), model zct300 22.5 diopter was explanted from the patient's right eye (od) as the toric lens dislodged and due to anatomical issue.It was indicated that the lens was implanted in a 14 year old male.The original surgery was performed by the first doctor.Based on the recommendation of the anesthesiologist, the patient was referred to another facility for patient's second eye surgery in order to receive general anesthesia.Upon consult with the other doctor, it was noted a part of the lens had moved into the anterior chamber.According to the surgeon the patients tissue was too soft to have a toric posterior (pc) lens replaced, but rather had to have a pc lens sutured in.The replacement lens model and diopter was not provided.There was noted that there was no patient injury and that the patient is doing well.The device is not available for return.No additional 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.

• 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: 9353201
• Report Number: 9614546-2019-01053
• Device Sequence Number: 2659450
• Product Code: HQL
• UDI-Device Identifier: 05050474553378
• UDI-Public: (01)05050474553378(17)200215
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 02/15/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U225
• 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: 10/28/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT: UNKNOWN; 1MTEC30 CARTRIDGE, LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Date Report Sent to FDA: 01/01/2005