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

Model Number PCB00

Device Problems Fracture (1260); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

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 and therefore not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The surgery center reported that they had a pcb00 19.5 diopter that when the surgeon went to inject the lens, the cartridge started to split.The surgeon saw it right away and did not use the device.The customer is unsure if the tip was damaged but indicated that by looking at the pcb00 it appears the tip may be damaged.It was confirmed that there was no patient contact/no patient issues.No further information was provided.

Manufacturer Narrative

(b)(4).All pertinent information available to johnson and johnson vision surgical, inc.Has been submitted.

Manufacturer Narrative

Additional information provided by the surgery center indicated that the scrub nurse was not familiar with the lens and they went through three lenses in total.That the nurse messed up their first lens, the second one had the reported damaged end (damaged cartridge) and the third lens was implanted successfully.It was confirmed that the lens with the damaged cartridge was actually serial number (sn) (b)(4) and that the lens with sn 5843481708 was the one that was implanted.The following fields were updated accordingly: (b)(4).Device available for evaluation? yes.Returned to manufacturer on: 8/2/2018.Device returned to manufacturer? yes.Device evaluation: the returned pcb00 device was received with the plunger in advanced position(override).The pcb00 device was observed under microscope and no viscoelastic residues were observed.Dfu (direction for use) states to completely fill the viewing window of the pcb00 with ovd (ophthalmic viscosurgical device).The lens was observed damaged and stuck in the cartridge tube and tip.The cartridge was observed positioned with the deformed and cracked cartridge tip.This condition appears to be caused by the lens in the attempt to be delivered since the lens stay stuck due to the lack of viscoelastic.The complaint was verified; however, it could not be related to the manufacturing process, but it could be related to handling process.No product quality deficiency was identified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other complaint has 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: as a result of the investigation 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
• MDR Report Key: 7640947
• MDR Text Key: 112430933
• Report Number: 2648035-2018-00913
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)200822
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/22/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• 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: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1