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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2: date of birth: unknown, asked but not available.Section a4: patient weight: unknown, asked but not available.Section a5: ethnicity and race: unknown, asked but not available.Section h3: other 81: the device was not returned for evaluation.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.
Event or Problem Description
It was reported that za9003 intraocular lens was implanted in the patients right eye.The patient was blurry since the original surgery.Patient also had refractive surprise, halos and visual disturbance.The lens was explanted in the secondary surgery and replaced with competitor lens.Directions for use were followed.No incision enlargement or sutures or vitrectomy.Symptoms persisted for 5 months.Patient was fully recovered.No other information is available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 4/13/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in pieces.No defects that could contribute to visual issues were observed.Based on the returned condition of the lens no further evaluation could be performed.Conclusion: the complaint issue blurry vision, visual disturbance, halo vision, unexpected postop refraction and explant could not be confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical codes and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16753449
• Report Number: 3012236936-2023-00949
• Device Sequence Number: 18274833
• Product Code: HQL
• UDI-Device Identifier: 05050474529045
• UDI-Public: (01)05050474529045(17)270726
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female