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

Model Number PCB00

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.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 Description

Customer reported that a pcb00 preloaded device cartridge tip split upon depressing the plunger, during handling, but prior to insertion of the lens.There was no patient contact reported.No additional information provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 5/9/2018.Device returned to manufacturer? yes.Device evaluation: the returned pcb00 device was received inside the original box.The plunger was observed in an advanced position.The pcb00 device was observed under microscope with a scarce amount of viscoelastic residue observed.The directions for use (dfu) state to completely fill the viewing window of the pcb00 with ophthalmic viscosurgical device (ovd).The lens was observed stuck in the cartridge tube and tip with the pushrod adhered to it.The cartridge was observed positioned with the cartridge tube and tip broken.The condition of the returned product appears to be caused by the attempt to deliver a lens that was stuck due to the scarce amount of viscoelastic used.The complaint was verified, however it could not be related to the manufacturing process but to the handling 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.A search revealed that no other complaint was received from 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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7505630
• MDR Text Key: 107963808
• Report Number: 2648035-2018-00686
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558298
• UDI-Public: (01)05050474558298(17)201219
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/19/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1