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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone no.: (b)(6).The device is not returning for evaluation by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported that during the loading of the lens in the preloaded system, the haptics have broken.No contact with the patient's eye and no patient involvement.Material is not available for investigation.No further details have been provided.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 11 aug 2021 section h3 - device evaluated by manufacturer? yes device evaluation: a visual evaluation was performed on the returned material.The lens was returned outside of the preloaded pcb00 system, which was in advanced position, and no haptic damage was observed.Therefore the complaint issue could not be confirmed.The condition in which the sample was returned is consistent with a product that was handled and prepared for a surgical process and a production deficiency could not be determined.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: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12276116
• Report Number: 2648035-2021-08239
• Device Sequence Number: 11484480
• Product Code: HQL
• UDI-Device Identifier: 05050474558328
• UDI-Public: (01)05050474558328(17)240301
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 03/01/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1