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

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h3-81: the device was not returned for evaluation as it remains implanted in the patient¿s ocular sinister (left eye).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
After the zcb00 model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye), there was reportedly a small irregularity outside of the optic that could not be polished off.The iol remains implanted as the small irregularity was visually insignificant and the patient has not reported any visual issues related to the small irregularity.It is unknown if there was a procedural delay however, there was no incision enlargement, medical attention, medication prescribed, suture(s), or vitrectomy.There are no plans for medical/surgical intervention to address the small irregularity.Post-operative vision was reported as: 1d - uc 20/30 | 1w - bc 20/20, pre-operative vision information, however, is unknown.Patient's daily activities are not significantly affected and she has fully recovered.No further information is available.
Additional Manufacturer Narrative
Additional information was received providing patient pre-operative vision information: uncorrected visual acuity (ucva) 20/100.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: 18044533
• Report Number: 3012236936-2023-02756
• Device Sequence Number: 18206421
• Product Code: HQL
• UDI-Device Identifier: 05050474531819
• UDI-Public: (01)05050474531819(17)261228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 11/12/2023

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000250
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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
• Patient Sex: Female