MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM; POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable, the lens was not implanted.If explanted; give date: not applicable, the lens was not implanted.Phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported issues with a model pcb00 intraocular lens (iol).The lens got damaged during handling but prior insertion into the patient's eye.No contact with patient's eye, the lens is not biologically contaminated.No further information has been provided.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Section d9 - returned to manufacturer on: 4/30/2021.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection was performed on the intraocular lens (iol) returned.The plunger and pushrod was observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.This probably could have caused the lens to get damaged during this process.Residues of viscoelastic material was observed on cartridge.The cartridge tip was observed deformed.The lens was also observed stuck in cartridge.It was too hard to remove the lens from the cartridge to address the condition reported.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 prepare for surgical process.The complaint issue reported could not be verified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
• Common Device Name: POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11742473
• Report Number: 2648035-2021-07704
• Device Sequence Number: 17232633
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)231001
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 10/01/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1