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

Model Number	ZCT150
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was not implanted.If explanted; give date: not applicable as the lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported an orange object was noticed when advancing the zct150 13.5 diopter intraocular lens(iol) in the cartridge.Through follow up, additional information was provided confirming no patient contact, no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.The procedure was completed successfully using the primary lens choice with the same model and diopter size.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/07/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a cartridge.Visual inspection with the unaided eye shows the product is stuck in the cartridge.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no similar complaints were received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.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.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8205395
• Report Number: 9614546-2018-01223
• Device Sequence Number: 263053
• Product Code: HQL
• UDI-Device Identifier: 05050474552012
• UDI-Public: (01)05050474552012(17)210406
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 04/06/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/21/2019; 10/25/2020
• Initial Report FDA Received Date: 12/30/2018
• Supplement Report FDA Received Date: 03/19/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005