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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable; as there is no indication the lens has been explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that sediment was found on the posterior part of a pcb00 9.0 diopter intraocular lens (iol) after implantation.Reportedly, the doctor stated the sediment could be seen when the lens unfolded and was concerned about lifting the haptic to wash underneath.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on 12/19/2017.Device evaluation: the actual lens was not returned for investigation.However, the reported foreign material/sediments were returned and investigated.A photo provided by the customer was evaluated but it was not possible to identify the sediment reported by the customer.There was something shiny circled but the light does not allow identify if it is sediment or another particle.The returned specimen was investigated by fourier-transform infrared spectroscopy (ftir) analysis and the results indicate that the foreign material is cellulose (like cotton, rayon, lint) and an acrylic species possibly mixed with protein.It was confirmed that exposure to cellulose is possible during the manufacture of the lens; but it is not possible to confirm if the particle observed is related to manufacturing as the reported lens was handled and prepared for surgical procedure.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: based on the investigation, there is a potential indication of a product quality deficiency since exposure to cellulose is possible as it is a component commonly found on paper, cotton, rayon, and lint.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 92705
• MDR Report Key: 7036033
• Report Number: 2648035-2017-02097
• Device Sequence Number: 1423885
• Product Code: HQL
• UDI-Device Identifier: 05050474558045
• UDI-Public: (01)05050474558045(17)190422
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 04/22/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1