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

Model Number	ZCT525
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during insertion into the eye, an intraocular lens (iol) appeared to have scuff marks on it.Reportedly, the lens was removed and replaced with a back-up lens.The patient was reported being fine.No further information was provided.
Additional Manufacturer Narrative
Additional information: the customer confirmed during follow up that: there was no incision enlargement, sutures were not used and a vitrectomy was not performed.Device evaluation: product testing could not be performed because the product was not returned.The reported issue was not 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) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6282014
• Report Number: 9614546-2017-00053
• Device Sequence Number: 1564183
• Product Code: HQL
• UDI-Device Identifier: 05050474603615
• UDI-Public: (01)05050474603615(17)201208
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: Physician
• Device Expiration Date: 12/08/2020
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 09/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1