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

Model Number	ZXT150
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not used.If explanted, give date: not applicable as the lens was not used.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
Reportedly, during opening of the zxt150 17.5 diopter intraocular lens (iol) package, the technician noticed a scratch on the lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 7/3/2017 device returned to manufacturer? yes.Device evaluation: the product was received for investigation.The pouch was opened, and inside there was a closed lens case.The lens was lying loose in the pouch.Visual inspection shows that the lens was prepared for use; material was present on the lens that appears to be dried viscoelastic.On the optic, some surface damage that looks like a scratch could be seen.Investigation of the return sample and the condition of the return sample do not suggest the scratch was introduced during manufacturing.The reported issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6598962
• Report Number: 9614546-2017-00481
• Device Sequence Number: 18998243
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)211208
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: Physicist
• Device Expiration Date: 12/08/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1