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); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
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 6 out of 9 reports that are being submitted as initial individual mdrs.Date of birth or age at time of event: unknown/no information.Sex: unknown/no information.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 lubricant material was observed on cartridge.The cartridge tip was observed crack.The lens was also observed exposed and stuck at the cartridge tip section.It was too hard to remove the lens from the device.However, no manufacturing defects were observed that could impair functionality in the device.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.Due to the conditions of the lens returned inside the device, the complaint issue reported as lens damaged could not be 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
It was reported that the technician heard an unusual noise when handling the preloaded intraocular lens (iol) and considered it to be defective.There was no patient contact.The procedure was completed using another lens of the same model and diopter.Through follow up it was learnt that as the technician proceeded to push the lens loader forward to the second mark on the loader as was standard protocol, a crunch noise was heard rather than hearing the typical slight click sound.The crunching sound was believed to have come from where the lens was located and that the lens had been crunched or became unusable.The technician indicated that the lens must have been placed in the lens insertor improperly, which was verified by the doctor upon examining under the microscope.Therefore, the lens was determined not safe to use.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: 12177916
• Report Number: 2648035-2021-00092
• Device Sequence Number: 11602194
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)230729
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Nurse
• 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: 07/29/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• 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