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

Model Number	PCB00
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not used.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
Reportedly, during opening of the pcb00 7.0 diopter intraocular lens (iol) package, the technician noticed a scratch on the lens.The lens was not used.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 07/06/2017.Device returned to manufacturer? yes.Device evaluation: the product was received for evaluation.Visual inspection at 10x microscope magnification was performed.The plunger and pushrod were not in the advanced position in the preloaded insertion system.No assembly error and/or defect were observed in the preloaded insertion system related to the manufacturing process.Residues of viscoelastic solution were not observed on the cartridge.The lens was observed properly seated in the lens storage area of the lower body.The lens was removed from the preloaded system to perform a visual inspection.Loose particles were observed on the lens related to the handling of the unit out of a sterile environment.No product damage was observed to the lens.Based on the evidence observed, it can be concluded that the preloaded insertion system was not used.The reported issue 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 investigation request 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 ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6599892
• Report Number: 2648035-2017-00964
• Device Sequence Number: 10825055
• Product Code: HQL
• UDI-Device Identifier: 05050474558007
• UDI-Public: (01)05050474558007(17)200302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/14/2017

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: 03/02/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 07/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1