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

Model Number	ZCB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable as the lens was removed and replaced in the initial procedure.If explanted, give date: not applicable as it was a removed and replaced in the initial procedure.Initial reporter name: unknown, information not provided.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed loose particles on the lens surface, which indicates the product was handled.The surface of lens was observed ripped/torn.The injector was not returned for evaluation.The reported issue was verified.However, it could not be determine if the damage observed in the returned lens sample was a result of the lens being handled during the surgical process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the doctor noticed after implantation that a zcb00 12.0 diopter intraocular lens (iol) was damaged by the inserter.The lens was removed and replaced.Reportedly, there was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 8/23/2017.Device returned to manufacturer? yes.Device evaluation: the complaint unit was received in the original folding carton.Visual inspection at 10x microscope magnification was performed.Loose particles were observed on the lens surface that could be related to the handling of the unit in a non-sterile environment.The surface of the lens was observed ripped/torn.The injector was not returned for evaluation (it had been thrown away).The reported issue was verified.However, it could not be determine if the observed defect was related to the manufacturing process or was a result of the lens being handled during the surgical process.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: 6871411
• Report Number: 2648035-2017-01667
• Device Sequence Number: 637201
• Product Code: HQL
• UDI-Device Identifier: 05050474531550
• UDI-Public: (01)05050474531550(17)210213
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/14/2017

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: 02/13/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/17/2017
• Supplement Report FDA Received Date: 10/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1