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

Model Number	ZCT525
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: unknown, information not provided.Initial reporter name: unknown, contact name not provided.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct525 15.0 diopter intraocular lens (iol) would not center properly.The doctor tried rotating the iol, but decided to explant the lens on (b)(6) 2017.Another lens, same model and diopter did not work, so the doctor replaced the lens with a non-amo anterior chamber iol.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported that the doctor's name is (b)(6) and her address is (b)(6), including a phone number of (b)(6).Also, the patient is a (b)(6) year old female.It was also reported that the implant date was (b)(6) 2016.In addition, there was no incision enlargement or vitrectomy performed.However, a capsular rent (tear) was reported to have happened, but when it happened was not provided.No additional information was provided.Age/date of birth: (b)(6).Gender/sex: female.If implanted, give date: (b)(6) 2016.(b)(6).Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6938984
• Report Number: 9614546-2017-00968
• Device Sequence Number: 19100421
• Product Code: HQL
• UDI-Device Identifier: 05050474603479
• UDI-Public: (01)05050474603479(17)210407
• Combination Product (Y/N): N
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 04/07/2021
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/18/2017
• 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: 50 YR