MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The doctor found a scratch near the optic of the intraocular lens (iol).There was no patient involvement or injury.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the complaint unit zcb00 (tecnis 1-piece) was received in its original box.Visual inspection using microscope magnification was performed.Dry viscoelastic residues were observed in the lens optic body and haptics.No scratches were observed on the returned lens.The condition observed is consistent with a lens that has been handled and prepared for surgical use.The reported issue could not be 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 additional 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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7153740
• Report Number: 2648035-2017-02389
• Device Sequence Number: 13919075
• Product Code: HQL
• UDI-Device Identifier: 05050474531536
• UDI-Public: (01)05050474531536(17)210505
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 05/05/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1