MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS ITEC PRELOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown / not provided.If implanted; give date: unknown / not provided.If explanted; give date: unknown / not provided.(b)(6).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported on an issue that a customer had a lens defective.No further information has been provided.
Additional Manufacturer Narrative
Additional information: section b3 - date of event: (b)(6) 2021 section b5 - describe event or problem: additional information confirmed that there was no contact with patient's eye; the lens was not partially or totally inserted in the patient's eye.The issue was noticed before implantation and the defect noticed in the lens was stuck in cartridge.Corrected data: section h6 - medical device problem code: 2524 - failure to advance based on the new information, this event is no longer considered reportable.Therefore, no further follow-up will be sent out under medwatch 2648035-2021-08238.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: 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: 12256300
• Report Number: 2648035-2021-08238
• Device Sequence Number: 17118700
• Product Code: HQL
• UDI-Device Identifier: 05050474558311
• UDI-Public: (01)05050474558311(17)231216
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 12/16/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1