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

Model Number	ZCT225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
After the intraocular lens (iol) was fully inserted, the doctor noticed a scratch on the lens.Therefore, the doctor removed it and replaced it with the backup iol of the same model and diopter.The patient is fine.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: visual inspection with the unaided eye shows the lens case was received opened with no lens in it.Further examination shows that the lens was found loose inside the biohazard packaging.The product was inspected by a qualified inspector using 12x microscope magnification.Inspection showed that the lens was cut and had a long scratch in the middle of the lens.Cosmetic issue was confirmed however how and when the scratches were introduced could not be determined.This type of scratch will be rejected during final inspection in manufacturing.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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6906329
• Report Number: 3011852734-2017-00019
• Device Sequence Number: 1142386
• Product Code: HQL
• UDI-Device Identifier: 05050474552777
• UDI-Public: (01)05050474552777(17)210606
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: 06/06/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1