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

Model Number	PCB00
Medical Device Problem Codes	Crack (1135); Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was removed and replaced in the same procedure.Device available for evaluation? yes; returned to manufacturer on: 04/20/2018; device returned to manufacturer? yes; device evaluation: the plunger was observed advanced and locked as the sample preparation required.The lens was received out of the device, inside the protective cap.The lens did not have any damages.The cartridge tip was stretched and cracked, which could be result of the pushrod tip.There was no viscoelastic residues observed inside the cartridge.Based on this evaluation, the reported complaint was not confirmed and no product deficiency was identified.Manufacturing record review: 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 additional 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.
Event or Problem Description
It was reported that cartridge cracked while inserting pcb00 intraocular lens into the patient's eye.It was noted that there was also folding/unfolding issue with the lead haptic.Therefore, iol has to be removed from the patient's eye and replaced with other pcb00 lens.There was patient contact, but no patient injury reported, no incision enlargement and no suture required.No additional information provided.

• 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: 7542184
• Report Number: 2648035-2018-00770
• Device Sequence Number: 2436129
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)191214
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 12/14/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1