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

Model Number	PCB00
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted and therefore not explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model pcb00) did not come out of the cartridge after the second push.Reportedly, another pcb00 lens was implanted as a replacement.Additional information was received and it was clarified that the lens touched the patient''s eye.No incision enlargement and no patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 03/14/2018.Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.Visual inspection showed that the plunger was in advanced position and locked as required.There was no viscoelastic residue observed inside the cartridge.The intraocular lens (iol) was observed folded and stuck in the cartridge tip.The customer's reported complaint for stuck in cartridge was verified.However, as the device was handled, a product deficiency could not be identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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.All pertinent information available to johnson and johnson surgical vision, inc.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: 7287675
• Report Number: 2648035-2018-00279
• Device Sequence Number: 1475964
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)191223
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: 12/23/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1