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	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported issues with a pcb00.Defective as the intraocular lens (iol) legs came out badly.No contact with patient's eye, the issue was noticed at first during handling but prior insertion.No patient involvement reported.Material is not available for investigation.Customer has no further information than what has been provided in this form.

• 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: 11834233
• Report Number: 2648035-2021-07808
• Device Sequence Number: 19865867
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)240113
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: 01/13/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1