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

Model Number	ZA9003
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
Date of event: unknown, not provided, but the best estimate date is during 2020.Implant date: unknown/ not provided.Explant date: unknown/ not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.
Event or Problem Description
It was reported that a za9003 lens was noted with bent haptic issues.Unsure if they were bent upon opening or after being loaded.No further information provided.
Additional Manufacturer Narrative
Correction: b5: additional: subsequent follow up information received from the surgery center revealed that the there was no patient contact with the lens.Upon reviewing the complaint folder, it has been determined there was no patient contact with the lens, therefore the haptic damaged is no longer a reportable event per our reportable criteria.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 2648035-2021-07173.G8: correction: in review, of medwatch 2648035-2021-07173 and per new information received, this event has been assessed not reportable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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: 11270098
• Report Number: 2648035-2021-07173
• Device Sequence Number: 14386970
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)241122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 11/22/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1