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 Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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 2 out of 9 reports that are being submitted as initial individual mdrs.Additional information: 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.(b)(6).Device evaluation: visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position and locked as device required.Residues of lubricant material was observed on cartridge.The cartridge tip and tube were observed crack by the pushrod as its observed in the sample.The lens was also observed at the cartridge tip section.No other defect was observed to the device.It was too hard to remove the lens from the cartridge due the lens stuck in the cartridge.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 as rod stiff could not be verified.However, the complaint issue reported as cartridge crack was 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 when the nurse pushed the plunger forward they noticed the preloaded lens was harder and slower to push forward compared to other preloaded lenses that did not present with any issue as all went well.The surgeon later tried to implant the lens and noticed that the tip of the plunger almost pushed thru the cartridge.The doctor stopped the implantation and opened a new lens which was successfully implanted.No further information is available.

• 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: 12176220
• Report Number: 2648035-2021-00083
• Device Sequence Number: 11143420
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)230723
• Combination Product (Y/N): Y
• Initial Reporter Country: SE
• 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: 07/23/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• 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