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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2018 is provided as this is the date the rotation of the lens was diagnosed.Explant date: if explanted; give date: not applicable (n/a).The lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device 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.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Reportedly, the subject's left eye (os) zct300 intraocular lens (iol) was 177 degrees at their repositioning surgery on (b)(6) 2018, but noted to be at 165 degrees during follow-up visit on (b)(6) 2018 (12 degree rotation).The subject is doing well.No visual complaints and no additional repositioning are planned at this time.Uncorrected visual acuity (va) was 20/25 ou.And best-corrected va results were 20/15 right eye (od), 20/20 left eye (os) and 20/15 for both eyes (ou).No additional information provided.This report pertains to the left eye (os).A separate report (mfr# 3011852734-2018-00108) has been submitted to right eye (od).
Additional Manufacturer Narrative
Additional information received indicated that intraocular lens (iol) axis for the left eye was measured at 180 degrees at the subject's 6-month study visit.The implant date was also provided (b)(6) 2018.At this time, there is no indication that any other intervention has been planned or performed.If implanted, give date: (b)(6) 2018.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received reported that at the subjects 1-year study visit, the iol axis in the left eye was measured as follows: os: 176 degrees (04 degrees from 6-month visit location of 180 degrees) there is no planned interventions as a result of the new rotation.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, INC.; santa ana CA 92705
• MDR Report Key: 7631996
• Report Number: 9614546-2018-00602
• Device Sequence Number: 1872008
• Product Code: HQL
• UDI-Device Identifier: 05050474553279
• UDI-Public: (01)05050474553279(17)200722
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2019
• 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: Physician
• Device Expiration Date: 07/22/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 01/29/2019
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/07/2018; 02/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005