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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, it was reported the dcb00 model intraocular lens (iol) was broken and there was no patient involvement.The procedure was completed using a non-johnson & johnson iol, hoya, that was implanted in the patient's ocular dexter (right eye).No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female section a-4 patient weight: unknown, information was not provided.Section a-5 patient ethnicity: unknown, information was not provided.Section a-6 patient race: unknown, information was not provided.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section e-1 reporter telephone number: (b)(6) - field only accepts the us phone number format.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 12-jan-2026.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the simplicity corresponding to this complaint was received loose inside the original folding carton.The dfu, implant notification card, patient stickers, implant identification card, and a non-j&j pouch was also received.No lens was received for evaluation.During a visual inspection, the device was inspected under magnification.The handpiece was received with the plunger rod fully advanced, and the plunger rod tip was bent.Viscoelastic residue was observed throughout the cartridge.The cartridge tip and cartridge was damaged.No issues were observed with the lens module, device assembly, and plunger rod advancement.Complaint issue "dc-lens damaged" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 23735501
• Report Number: 3012236936-2025-000325
• Device Sequence Number: 9687195
• Product Code: HQL
• UDI-Device Identifier: 05050474636118
• UDI-Public: (01)05050474636118(17)271101
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: DCB00
• Device Catalogue Number: DCB0000215
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female