MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION TECNIS; TORIC IOLS

Model Number	ZCT300
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that during implant of the intraocular lens (iol), the lens did not unfold and was stuck in delivery device.Reportedly, there was no patient injury and no sutures used.The lens was replaced with the same model and size lens.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 10/1/2018.Device returned to manufacturer? yes.Device evaluation: the product was received in its original packaging.Visual inspection under 12x microscope magnification was performed by a qualified final inspection manufacturing specialist.Both lens haptics were observed in good condition with no abnormalities.There were scratches found on the optic.However, product will be rejected if such defect is found during manufacturing.Lens was further measured.All measurements (haptic width, optic diameter, overall diameter and haptic thickness) were within specification.Scratches were observed, however, when and how the defect occur cannot be determined.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.
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 AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7924635
• Report Number: 3011852734-2018-00173
• Device Sequence Number: 1806883
• Product Code: HQL
• UDI-Device Identifier: 05050474553422
• UDI-Public: (01)05050474553422(17)211030
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 10/25/2020
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/26/2018; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005