MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens is still in the eye.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient developed tass (toxic anterior segments syndrome) post implant of a zmb00 intraocular lens.Additional information was provided by the surgical site and it was learned that two weeks after onset, tass was still present.Further follow up confirmed the lens is still implanted and the adverse event was not related to the lens.The patient was placed on durezol every hour in the operated eye.
Additional Manufacturer Narrative
Additional information was received stating that toxic anterior segment syndrome continued as noted on (b)(6) 2016 and also it was indicated that the serious adverse event is not related to use of concomitant medication(s).No further information was provided.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received which indicated the reported issue of toxic anterior segment syndrome had resolved on (b)(6) 2016.Device evaluation: the lens was not returned to the manufacturer for evaluation as the lens remains implanted.Visual inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.The lenses were released according to specifications.The complaint history search revealed no other complaints for this production order number has been received.Sterilization batch review was conducted.The sterilization batch was released per specifications.There were no non conformances with respect to the sterilization process.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5926978
• Report Number: 9614546-2016-00436
• Device Sequence Number: 945772
• Product Code: MFK
• UDI-Device Identifier: 05050474535602
• UDI-Public: (01)05050474535602(17)181119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2016

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: Health Professional
• Device Expiration Date: 11/19/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/02/2016
• Supplement Report FDA Received Date: 09/18/2016; 10/19/2016
• 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: 74 YR