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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not applicable, as the lens remains implanted.Toxic anterior segment syndrome (tass).Attempts have 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 patient developed toxic anterior segment syndrome (tass) after having an implantation of a zct225 23.0 diopter intraocular lens (iol) on (b)(6) 2017.Reportedly, the patient appears to be improving or responding to treatment.Further information received from the doctor (b)(6) 2018, states that the patient has not recovered but he doesn''t believe the lens is the suspect product.He believes it was the sleeves used which was the only variable between the patients he saw that day.The doctor did not specify the type of treatment the patient was undergoing.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.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 other complaints have been received for this production order number.Sterility records review: sterilization batch report was reviewed, which includes biological indicator test and process parameters and met all the requirements.This sterilization lot also passed the bacterial endotoxin test and was within the established safety levels of endotoxin.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 92705
• MDR Report Key: 7177036
• Report Number: 3011852734-2018-00003
• Device Sequence Number: 16410793
• Product Code: HQL
• UDI-Device Identifier: 05050474552791
• UDI-Public: (01)05050474552791(17)210911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/06/2018

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: 09/11/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/06/2018
• 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