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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable, the lens was not used.If explanted; give date: not applicable, the lens was not used.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that intraocular lens (iol) was cracked.Reportedly, the lens as found cracked upon opening the package.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 4/06/2018.Device evaluation: the pcb00 device was returned to the manufacturer.The plunger was observed almost advanced.The pcb00 device was observed under microscope and scarce amount of viscoelastic residues were observed in the cartridge tip and tube.Dfu states to completely fill the viewing window of the pcb00 with ovd.The lens was observed stuck at the loading zone of the cartridge with the pushrod overriding the lens.This condition could be caused by the scarce amount of viscoelastic observed which causes the lens to stuck and due to the forces performed the pushrod overrides the lens.The lens was removed from the pcb00 device and no residues were observed in the optic zone.The lens was observed torn by one side near to ones of the haptics that was observed detached and missing.This condition could be caused by the scarce amount of viscoelastic observed which causes the lens to stuck and due to the forces performed the pushrod overrides and broken the lens.The complaint was verified, however due the condition of the sample received it could not be related to the manufacturing problem.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.A search in complaint history revealed that no other complaints have been 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): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7426438
• Report Number: 2648035-2018-00503
• Device Sequence Number: 13480789
• Product Code: HQL
• UDI-Device Identifier: 05050474558434
• UDI-Public: (01)05050474558434(17)191107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/12/2018

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: 11/07/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1