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

Model Number	ZCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during handling, but prior to insertion, some fine debris was noticed on the optic of a zcb00 13.5 diopter intraocular lens (iol).Also, it was reported that the plastic piece that the lens comes in looked damaged, but the box and sterile pouch were intact.The lens was not loaded and the same model and diopter was implanted.Reportedly, there was no incision enlargement or sutures used.There was no patient contact.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 11/17/2017.Device returned to manufacturer? yes.Device evaluation: only the lens case/ insert and lens inside a plastic bag were returned.Loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.No plastic piece was identified on lens.No damaged was observed to the lens and lens haptics.The complaint issue reported 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 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 92705
• MDR Report Key: 6975397
• Report Number: 2648035-2017-01935
• Device Sequence Number: 649398
• Product Code: HQL
• UDI-Device Identifier: 05050474531581
• UDI-Public: (01)05050474531581(17)200614
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 06/14/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR