MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that upon preparing for insertion, the doctor noticed that the tip of the pcb00 inserter showed an abnormal shape.Under the surgical microscope, it was confirmed that the top edge of the tip was blunt as if it was crushed.There was no misuse or wrong manipulation by the scrub nurse nor surgeon.The packaging of lens was intact.Another lens was used to implant and the suspected defective lens was discarded.There was no adverse event for the patient.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 5/18/2018.Device returned to manufacturer? yes.Device evaluation: the product was received and photos of the pcb00 were evaluated.The lens could be observed at the cartridge tube indicating the pcb00 was prepared for insertion, which is consistent with information provided on the initial report.The plunger component was observed in advanced position.The plunger was gently pulled back and found locked.Cartridge was observed correctly engaged into lower body of the pcb00 device.No assembly defects are observed on the device.Visual inspection with magnification was performed.The lens was observed stuck at the cartridge tube.The cartridge tip is deformed.There is no viscoelastic in the device; directions for use include to completely fill the viewing window with ophthalmic viscoelastic device (ovd).The reported issue was verified.Based on the visual evaluation of the returned unit it could not be determined that the cause of the issue reported is related to the manufacturing process.No product quality deficiency was identified.Manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.Labeling review: the 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): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7559367
• Report Number: 2648035-2018-00808
• Device Sequence Number: 14073937
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)200308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 03/08/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1