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

Model Number	PCB00
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that while inserting the monofocal intraocular lens (model pcb00 +11.5 diopter) into the eye, the haptic would not unfold.The lens was removed.There was patient contact.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 02/23/2018.Device evaluation: the lens was returned to the manufacturer.The plunger of the device delivery system was observed in the advanced position.The cartridge was correctly engaged into lower body of the pcb00 delivery device.Neither assembly error nor a defect related to manufacturing process was observed.Visual inspection was performed at 10x microscope magnification.Lack of lubricant material was observed in the device.The lens was stuck in the cartridge tube with the haptic not folded.The reported issue was verified.However, the condition of the returned lens is consistent with a product that was handled and prepared for a surgical process.Manufacturing record review: manufacturing record review and related documents revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no similar complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson & 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: 7284598
• Report Number: 2648035-2018-00273
• Device Sequence Number: 10796957
• Product Code: HQL
• UDI-Device Identifier: 05050474558090
• UDI-Public: (01)05050474558090(17)190714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 07/14/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1