MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS

Model Number	ZCT600
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.The lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct600 15.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.Post-operatively, at the 1 month follow up visit with the doctor, the lens had rotated out of place by about 15 degrees.The patient also reported blurry vision.Therefore a lens repositioning procedure is planned to improve vision.No additional information was provided.
Additional Manufacturer Narrative
Based on new information received on april 27 & 30, 2018; the doctor decided to rotate lens back to suggested axis of 14 from toric calculator.The iol repositioning was done on (b)(6) 2017, and the patient is doing well.Iol is not going to be removed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received reported that the event was not an iol rotation as previously reported.However the lens was repositioned on (b)(6) 2017 and repositioned to the correct the axis (measured at 15 degrees).Reportedly, the amo toric calculator said that the lens should be placed at 14 degrees, however, during surgery on (b)(6) 2017, the doctor used an ocular response analyzer (ora) and placed the lens at 174 degrees instead.At the one-month post-operative visit, the doctor realized/decided that the lens should have been placed at 14 degrees.No additional information was provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received reported the doctor reported that the lens rotated from 174 degrees to 179 degree, so he rotated the lens back to the axis of 15 degrees in a second surgical procedure.No additional information was provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.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 the specifications.A search revealed that no similar complaints were received from 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: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7149980
• Report Number: 9614546-2017-01271
• Device Sequence Number: 13684763
• Product Code: HQL
• UDI-Device Identifier: 05050474604070
• UDI-Public: (01)05050474604070(17)210406
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/25/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 04/06/2021
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/11/2018; 02/02/2018; 04/10/2018; 04/27/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/07/2018; 03/02/2018; 05/09/2018; 05/25/2018
• 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