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

Model Number	ZXT225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted/explanted; give date: n/a (not applicable).The intraocular lens was not implanted.Device evaluation: the product was returned for investigation with a note on the package stating: ¿no patient contact and lens damaged.¿ in the package was a wheel case in an open pouch, an implant notification card and some labels.The wheel case was placed in the pouch with the identification label facing downward.The label could not be seen.This indicates that the lens case was taken out of the inner pouch.The iol was on the outside of the daisy wheel.The product was inspected by a qualified final inspection operator using 12x magnification.There were some scratches in the center of the iol, but no other anomalies.Investigation of the returned sample and the condition of the return sample do not suggest the scratches were introduced during 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.
Event or Problem Description
It was reported that the intraocular lens (iol) was not inside the normal container area, and it seemed glued to the back of the iol container.The issue was noticed when removing the iol from the packaging.There was no patient contact.Additional information was received with the product return indicating that the iol was damaged.The returned iol was inspected and was observed to be scratched.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6809411
• Report Number: 9614546-2017-00785
• Device Sequence Number: 1735700
• Product Code: POE
• UDI-Device Identifier: 05050474605770
• UDI-Public: (01)05050474605770(17)211017
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: Physician
• Device Expiration Date: 10/17/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1