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

Model Number	ZCB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some black dots had been found on the surface of the optic of the non-preloaded monofocal intraocular lens (iol) right after implantation and the surgeon decided not to exchange iol on the day but iol exchange may happen depending on the patient's discomfort and post-op result.No further information is available.
Additional Manufacturer Narrative
Section a6: patient information not provided due to personal data privacy legislation/policy.Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section e1: reporter email address: unknown, information not provided.Section e1: reporter telephone number: (b)(6).Section h3: the device was not returned for evaluation as the lens remain implanted in the eye.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information and correction: additional information received on 4/24/2025 stated that the surgeon confirmed that the "black dots found on the surface of the optic¿ are not foreign material because she tried to remove it during the surgery but nothing was improved.So, she thought this issue is associated with lens optic itself.These black dots did not lead to visual impairment and patient does not feel any discomfort after surgery.Doctor decided not to exchange intraocular lens (iol) since there was no visual impairment.Based on above additional information, the event is assessed as not reportable.There will no longer be any further reporting under mfr report number 3012236936-2025-0001108.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Initially reported that some black dots had been found on the surface of the optic of the non-preloaded monofocal intraocular lens (iol) right after implantation and the surgeon decided not to exchange iol on the day but iol exchange may happen depending on the patient's discomfort and post-op result.No further information is available.Additional information received on 4/24/2025 stated that the surgeon confirmed that the "black dots found on the surface of the optic¿ are not foreign material because she tried to remove it during the surgery but nothing was improved.So, she thought this issue is associated with lens optic itself.These black dots did not lead to visual impairment and patient does not feel any discomfort after surgery.Doctor decided not to exchange intraocular lens (iol) since there was no visual impairment.No further information is available.

• 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: 21869145
• Report Number: 3012236936-2025-000110
• Device Sequence Number: 12723125
• Product Code: HQL
• UDI-Device Identifier: 05050474531697
• UDI-Public: (01)05050474531697(17)280114
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: ZCB0000190
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown