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

Model Number	DIU225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded intraocular lens (iol) implanted in the patient's right eye had scuff marks.The patient also suffers from induced blur from higher order aberrations with the eyhance lens.An exchange is planned for a zcu toric model lens.Through follow-up, it was learned that the eyhance lens was explanted and successfully replaced with a different model and lower diopter (zcu150 18.5) johnson & johnson iol.The patient was taken to recovery with no complications.There was no vitrectomy, incision enlargement, or sutures required.The patient's vision post-operatively day (pod) #1 measured 20/20.No other information was provided.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that high order aberrations (hoa) was inadvertently not included as clinical code 4580.Therefore, it is captured in this supplemental report.The following section has been updated accordingly: section h6: health effect - clinical code: 4580.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device evaluation: a photo was received and evaluated.A picture shows the anterior segments of a pseudophakic eye claimed to be implanted with an eyhance toric ii simplicity iol, model diu225u.Customer provided photo shows an anterior segment photo taken with dark field technique, it is observed an intraocular lens with cylinder axis marks present in toric iols, and it can be observed several scuff-like marks distributed in a linear pattern and located in the mid periphery of the lens optical portion between 10:00 and 12:00.The origin, nature, and potential clinical impact of the observed phenomena cannot be determined from a picture evaluation.The complaint issue "cosmetic issues" was identified during sme evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 14414644
• Report Number: 3012236936-2022-01261
• Device Sequence Number: 5537840
• Product Code: MJP
• UDI-Device Identifier: 05050474747111
• UDI-Public: (01)05050474747111(17)241205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2022

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: 12/05/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U190
• Was Device Available for Evaluation?: No
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 08/14/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/22/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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: Other
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White