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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Device Contaminated During Manufacture or Shipping (2969); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initially included in vmsr filing 2648035-2021-00008.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 16 out of 20 reports that are being submitted as initial individual mdrs.Additional information: date of birth or age at time of event: not applicable, there was no patient contact.Sex: not applicable, there was no patient contact.If implanted, give date: not applicable iol was not implanted.If explanted, give date: not applicable iol was not explanted.Device evaluation: visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position residues of lubricating material were observed on cartridge.No damaged was observed to the cartridge and to the device.The lens returned outside the preloaded device.No damaged was observed to the lens.Tests revealed the debris to contain salt solution and a sulfur species (source unknown) and aluminum particles.There is no evidence to suggest that the particles in question came from device.There is no evidence of aluminum material as part of the manufacturing and packaging process of the pcb00 product.The presence of salt solution on the iol could be related to the use of bbs(balanced salt solution) during the surgical process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.There is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The complaint issue reported was not verified.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
Received report indicating the intraocular lens (iol) was defective/scratched and there was debris on the iol.The issue was noticed prior to patient contact and the iol was not inserted.There is no indication of intervention.No further 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: 12174875
• Report Number: 2648035-2021-00078
• Device Sequence Number: 19212816
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)221018
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• 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: 10/18/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• 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