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	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: not applicable, as there was no patient involvement.Section d6a: if implanted, give date: not applicable, as there was no patient involvement.Section d6b: if explanted, give date: not applicable, as there was no patient involvement.Section e1: telephone number:(b)(6) section h3: 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 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.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was missing its primary sterile pouch upon opening the box (secondary packaging).Only the syringe was present and the secondary packaging (box) remained correctly sealed and intact.There was no patient contact.The product is not available for evaluation.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: the suspect product was not received, however, the customer provided photographs.The photos were evaluated and shows the complaint product in the handpiece tray and the cartridge tip was observed to be bent.No further issues were identified.Due to no product received, no further evaluation was performed.The complaint issue packaging issues and sterility assurance concerns were not identified during photo evaluation.The other observed issues during the photo evaluation could not be confirmed to be related to the manufacturing or design process.The packaging procedure was reviewed and confirms that the unit pouch is visually inspected for any defects, scanned and verified to match the production order.The components are then scanned and placed inside the folding carton prior to sealing with a tamper evidence sticker.The scan log was reviewed, and it was confirmed that the unit pouch was scanned as per procedure.Based on review, no product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency or product malfunction.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: 24913915
• Report Number: 3012236936-2026-000100
• Device Sequence Number: 9800090
• Product Code: HQL
• UDI-Device Identifier: 05050474636187
• UDI-Public: (01)05050474636187(17)281021
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2026

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: DCB0000250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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