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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted; or explanted give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4) the intraocular lens (iol) is not returning for evaluation; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that zct150 + 17.5 intraocular lens (iol) was explanted from patient's left eye (os).Per account, patient was unhappy with loss of near vision.However, there was no patient injury occurred and no incision enlargement required.Iol exchanged with the same model and type number was performed without incident, but with different serial number, (b)(4).It was noted that patient had preexisting condition, glaucoma.Patient best corrected visual acuity results were 20/25 pre-operation and 20/20 post-operation.Product is not expected to be returned.No additional information provided.
Additional Manufacturer Narrative
The initial mdr incorrectly reported that the lens was removed and replaced during the same procedure within section with reference to sections.The following has been updated accordingly: if implanted; give date: unknown, information was not provided.If explanted; give date: unknown, information was not provided.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: 7657139
• Report Number: 9614546-2018-00631
• Device Sequence Number: 13719307
• Product Code: HQL
• UDI-Device Identifier: 05050474552098
• UDI-Public: (01)05050474552098(17)210804
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 08/04/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U175
• 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: 06/05/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005