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

Model Number	ZA9003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown, information not provided.The device will not be returned for analysis as stated by the customer.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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 & johnson surgical vision, inc.Has been submitted.Lens is not being returned.
Event or Problem Description
It was reported that a za9003 model intraocular lens(iol) was explanted from patient's right eye as the lens was slightly decentered and patient complained of blurry vision and also seeing the edge of lens.Incision enlargement and vitrectomy were not performed but sutures was done as a precaution.This event was observed during post operative examination.Additional details from follow up states that there was no patient injury.The replacement lens used is a same model but different diopter lens.Patient was discharged successfully without any complaints.Suspect product is not being returned.Patient/user outcome: visual acuity pre-operative: 20/30, visual acuity post-operative: 20/30.No further information provided.

• 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: 11344290
• Report Number: 2648035-2021-07271
• Device Sequence Number: 3347526
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)240905
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• 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: 01/21/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR