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

Model Number	ZCT225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was scratched and there was patient contact.The iol was removed from patient¿s ocular sinister (left eye) and a new lens was placed.Through follow up, additional information was received confirming an incision enlargement and unplanned suture(s) were required.There was no serious patient injury, no unplanned vitrectomy, and the procedure was completed successfully using backup lens of the same model and diopter size.Further information was received confirming the patient did well post procedure and vision was 20/30 post-procedure.No additional information was provided.
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: 18-may-2020.Section h-3 device returned to manufacturer: yes.Device evaluation: the complaint lens was received inside its original daisy wheel.Additionally, the original patient stickers and folding carton were received.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was implanted and then removed.The lens was cleaned, and a scratch was observed on the optic body, which may have occurred during the handling for insertion, implantation, or removal of the lens.The complaint issue was confirmed, however since the lens was handled it cannot be confirmed if this issue is related to manufacturing or handling, and therefore 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 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.
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: 10090466
• Report Number: 9614546-2020-00207
• Device Sequence Number: 3407003
• Product Code: HQL
• UDI-Device Identifier: 05050474552463
• UDI-Public: (01)05050474552463(17)221128
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U065
• 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: 05/04/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 10/25/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/04/2020; 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005