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); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: this event was initially included in vmsr filing 2648035-2021-00009.Due to the inclusion of other ancillary details that may appear as causes in the vmsr filing, this event is now being captured as an initial 30 day mdr.This report captures the event for serial number (b)(4).This is report number 9 out of 9 reports that are being submitted as initial individual mdrs.If explanted, give date: not applicable iol was not explanted.Device evaluation: the pcb00 product was returned in its original package.Visual inspection using magnification was performed to the returned sample.The plunger and pushrod was observed in advanced position.Residues of lubricant material was observed on cartridge.No damaged was observed to the cartridge and to the device.The lens was not returned.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported could not be verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the lens loading cartridge has a "burr on the end of it".A brief description of the issue provided that a little extra plastic/a bump that was not smooth as expected was noticed.The customer was able to successfully implant the lens.Through follow-up it was learnt that the burr was noticed when entering the incision.There were no difficulties with insertion.There was no noticeable change to the incision.The patient didn¿t require sutures and there was no need for vitrectomy.The patient visual acuity outcome is as expected.No other information was provided.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12178238
• Report Number: 2648035-2021-00097
• Device Sequence Number: 19672318
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)230210
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR