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

Model Number	PCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Explant date: if explanted; give date: n/a.The lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The surgeon noticed plastic debris that was introduced into the eye along with the intraocular lens (iol).The debris was small and located on the posterior side of the iol.Some of the debris was adhered to the lens itself, often around the 4 o'clock position.The surgeon had to aspirate the debris by going under the iol with an irrigation/aspiration tip after implantation and had to chase down the piece, sometimes having to remove it from the iol surface.This issue added time and difficulty to the procedure; however, there were no complications, incision enlargement or patient injury.The lens remains implanted and the patient outcome is excellent.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
The pcb00 preloaded insertion system was not returned for evaluation.The reported lens remains implanted.Pictures were provided for evaluation.From the pictures provided, the ''plastic debris'' in question could not be observed.The manufacturing records for the intraocular lens 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.The directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.The reported issue was not verified.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 ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5941523
• Report Number: 2648035-2016-01430
• Device Sequence Number: 16259318
• Product Code: HQL
• UDI-Device Identifier: 05050474558038
• UDI-Public: (01)05050474558038(17)190428
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2016

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: 04/28/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 10/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1