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); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: 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 9 out of 20 reports that are being submitted as initial individual mdrs.Date of birth or age at time of event: unknown/not provided.Sex: unknown/not provided.If implanted, give date: not applicable iol was not implanted.If explanted, give date: not applicable iol was not explanted.Upon further review it was noted that the patient moved while the iol was being inserted and the lens got stuck in the wound.Device evaluation: the cartridge component was observed correctly engaged into lower body of the pcb00 device.The plunger component was observed in a fully advanced position.Visual inspection using magnification was performed.The lens was observed in the preloaded lens cavity.The rod tip overrides the lens.Residues of lubricant were observed only at the cartridge tip.During sample evaluation, the lens was removed for evaluation.No damages were detected in lens.Base on the evidence observed, the unit was handled and used.The reported issue was not verified on the return.No product deficiency was identified.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 patient moved their head while injecting the lens into the eye.The iol got caught in the incision.Through follow-up the customer explained that the iol was partially inserted.There were no injuries to the patient.The procedure was completed with a backup iol.Reportedly, the lens was damaged during the removal process and no damage was noticed prior to the insertion.There was no use error reported.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: 12178139
• Report Number: 2648035-2021-00096
• Device Sequence Number: 3357070
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)230217
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 02/17/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• 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