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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The intraocular lens remains implanted.(b)(4).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) aligned at surgery based on ocular response analysis/analyzer(ora) but rotated 6 degrees (from 174 degrees to 180 degrees) 2 weeks post-op.The customer complains of some blurriness and too much residual astigmatism.Realignment was scheduled for (b)(6) 2018.The outcome does not significantly interfere with activities of daily life.There was no incision enlargement.The iol remains implanted in the left eye.It is unclear if the iol rotated due to patient activity or the iol itself.No additional information was provided to johnson & johnson surgical vision, inc.
Additional Manufacturer Narrative
Device evaluation: the lens remains implanted; therefore, it was not returned for investigation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: during follow-up, the following information was obtained: the lens was repositioned rotationally on (b)(6) 2018.There was no patient injury.The incision was not enlarged during the repositioning procedure.The patient is doing very well post-operatively.Two week post-operative on (b)(6) 2018, the patient showed a refraction of -0.25 sphere with an uncorrected vision of 20/20 and corrected vision of 20/16.No additional surgical procedures were performed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7310641
• Report Number: 9614546-2018-00209
• Device Sequence Number: 10982244
• Product Code: HQL
• UDI-Device Identifier: 05050474602953
• UDI-Public: (01)05050474602953(17)220731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/20/2018

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/06/2018; 03/21/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/02/2018; 04/20/2018
• 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: 71 YR