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

Model Number	PCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.(b)(4) - physical defect/huge gouge in the center of the posterior side of the optic all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had a physical defect/a huge gouge in the center of the posterior side of the optic.Reportedly, the lens was implanted and removed.No patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 06/14/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens was cut in two pieces.Fibers/particles and residue of viscoelastic solution were observed on the lens, indicating that the unit was handled and prepare for surgical use.The reported gouge was observed on the center of the lens optic.The customer's reported complaint was verified.However, the lens was previously handled for surgical use.Therefore, it could not be determined that the defect observed was related to the manufacturing process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.

• 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: 6596402
• Report Number: 2648035-2017-00961
• Device Sequence Number: 1148391
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)180826
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/06/2017

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: 08/26/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 05/29/2017
• Supplement Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1