MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS CL IOL; INTRAOCULAR LENS

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown, information not provided.Date of event: unknown, not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of the intraocular lens (iol) sheared.No further information provided.
Additional Manufacturer Narrative
Section b5: additional information received from the surgery center revealed that there was no patient contact with the lens/ cartridge.Upon reviewing the complaint folder, it has been determined as there was no patient contact with the lens, the reported haptic damaged is no longer considered a reportable event.Therefore, no further information will be submitted under medwatch 2020664-2021-07547.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• 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: 12538286
• Report Number: 2020664-2021-07547
• Device Sequence Number: 17169307
• Product Code: HQL
• UDI-Device Identifier: 05050474530744
• UDI-Public: (01)05050474530744(17)260104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 01/04/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1