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

Model Number	PCB00
Medical Device Problem Codes	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was not implanted.Device evaluation: visual inspection was performed to the photo provided.Residues of lubricant material were observed on the cartridge which indicated that the unit was handled and prepared for surgical use.The lens was observed stuck at the cartridge tip area.Cartridge was observed with a crack at the cartridge tube section.Dent/distortion was also observed on cartridge tip.The complaint issue reported was verified.However, based on the evidence observed, it is not possible to confirm if the defect observed is related to manufacturing, as the reported cartridge was handled and prepared for surgical use.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.
Event or Problem Description
It was reported that the scrub nurse prepared the intraocular lens (iol).The surgeon moved the plunger from the loaded to the locked position.When it locked, he heard a strange sound and then looked down at cartridge and saw that it had cracked and the iol was sticking out of the side.Cartridge tip damage was observed per a photo provided by the customer.No additional information was provided to abbott medical optics.

• 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: 7292377
• Report Number: 2648035-2018-00285
• Device Sequence Number: 11002286
• Product Code: HQL
• UDI-Device Identifier: 05050474558113
• UDI-Public: (01)05050474558113(17)190809
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: 08/09/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1