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); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
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 19 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.Device evaluation: there was lubricating material residues observed in the device.The lens and the pushrod came out the side of the cartridge.The cartridge was broken, and the lens looks torn.The reported issue was verified; however, due to the condition of the sample returned it is not possible to determine if it relate to the handling or to the manufacturing process.Based in the analysis product quality deficiency could not be determined.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.The investigation confirmed that the iol was torn and the cartridge was broken.Since the investigation results confirmed the iol was torn and since iol torn is a reportable malfunction then this event was reassessed as reportable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating the preloaded intraocular lens (iol) did not work properly.The technician loaded the lens and the lens came out through the side.There was no patient contact and no intervention was required.The procedure was completed successfully using another lens of different model.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: 12177702
• Report Number: 2648035-2021-00089
• Device Sequence Number: 11143422
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)230210
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: 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: 02/10/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• 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