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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that a zct300 14.5 diopter intraocular lens (iol) seems to rotate on its own and must be rotated back to its original position in the patient¿s ocular dexter (right eye).Through follow up, the customer account provided additional information confirming the lens rotated from 30° to 35° counterclockwise.The lens was not repositioned.Through a later follow up the customer account provided additional information confirming visual complaints of blurry and foggy vision that were first noticed on (b)(6) 2018.The zct300 lens was subsequently explanted and replaced with a model zct45 14.5 diopter lens.At explant, there was no incision enlargement, no suture(s) and no vitrectomy required.Patient outcome post exchange was reported as day 1 post-op great with visual acuity: 20/30.Day 2 post-op great visual acuity: 20/30+.At one-week post-op visual acuity was noted to be 20/70 and the replacement lens has rotated 10 degrees counterclockwise, the account is not sure if this is an issue due to the patient¿s anatomy.The patient will be evaluated at the one-month post-exchange exam to determine if further intervention is required.The event related to the replacement lens will be captured in a separate mdr.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not 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 according to specifications.Historical data analysis: a search of complaints revealed no similar complaints have been 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 confirmed as the product was not returned.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; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8067018
• Report Number: 9614546-2018-01075
• Device Sequence Number: 16191648
• Product Code: HQL
• UDI-Device Identifier: 05050474553217
• UDI-Public: (01)05050474553217(17)191210
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 12/10/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U145
• 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: 10/16/2018
• Supplement Date Received by Manufacturer: 12/21/2018; 10/25/2020
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/16/2019; 11/04/2020
• 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: 62 YR
• Date Report Sent to FDA: 01/01/2005