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

Model Number	DCB00
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a3b, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted 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.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.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was opened and noticed that the seal of the box was broken prior to use, leading to its destruction.From additional information it was learnt that product was not received with broken lens box seal.Reportedly there was a breach or potential breach in the sterile barrier that is not due to shipping damage or use error.The lens was not contaminated.No other information is available.
Additional Manufacturer Narrative
Based on additional responses and further review, the following sections have been updated to reflect changes.Addition response reveled that the pouch was already open.Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: april 21,2025.Section h-3: device evaluated by manufacturer: yes.Section h 6- device code(s): 1421 - delivered as unsterile product.Device evaluation: visual inspection under magnification was performed on the suspect product and found the original folding carton was received with the white seal torn.Additionally, the sterilization pouch was observed to be opened and crumpled; however, no sealing issues were observed.The complaint handpiece was received with the plunger rod fully retracted and with the lens inside the lens module; the device was unused.The product was forwarded to manufacturing site for further evaluation.The product was visual inspected and found the pouch was observed to be opened at the supplied sealed area.The complaint issue was identified during product 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.As part of the manufacturing process, during first pack inspection, operators inspect 100% for cleanliness and general appearance of pouched lenses according to packaging and boxing inspection for iols using a fluorescent magnifier lamp.Soiled smeared, discolored, distorted, damaged pouches or no satisfactory seals per specification are cause of rejection.Then, during the boxing inspection operators inspect each pouch according to procedures above mentioned.Based on the assessment performed, there is no indication that the complaint reported could be related to the manufacturing and/or supplier process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be 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: 21657368
• Report Number: 3012236936-2025-000075
• Device Sequence Number: 7424680
• Product Code: HQL
• UDI-Device Identifier: 05050474636149
• UDI-Public: (01)05050474636149(17)270125
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: DCB00
• Device Catalogue Number: DCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: Unknown