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

Model Number	DIU225
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	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2,a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable.Section d6b: if explanted, give date: not applicable.Section h3: other 81: customer photos were provided are evaluated.The photos display the suspect product original folding carton.The carton can be observed to be crumpled and bent, and with the seal torn.Due to no product received, no further evaluation could be performed.The manufacturing records review for this po shows that the units were released within specification.The complaint issue was identified during photo 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.The complaint issue was not identified during photo evaluation.Per procedure, folding cartons are individually inspected in manufacturing prior to movement to the distribution center and are individually inspected in the distribution center prior to placement in the shipping box.Based on the complaint investigation results, the product was released within specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the sterility of the preloaded intraocular lens was compromised.Additional information revealed that the packaging was crushed and the sterility seal was broken.A breach or potential breach in the sterile barrier of the device was noted.No further information is available.
Additional Manufacturer Narrative
Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: april 07, 2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the handpiece was received in a sealed sterilization pouch; no sealing issues were observed with the pouch.The original folding carton was inspected revealing it was received damaged and with the white seal open.No further evaluation was performed.The complaint issue was identified during photo and 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.The complaint issue "sterility assurance concerns" was not identified during photo evaluation.Per procedure, folding cartons are individually inspected in manufacturing prior to movement to the distribution center and are individually inspected in the distribution center prior to placement in the shipping box.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 IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21413342
• Report Number: 3012236936-2025-000032
• Device Sequence Number: 20891776
• Product Code: MJP
• UDI-Device Identifier: 05050474747142
• UDI-Public: (01)05050474747142(17)270715
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: DIU225
• Device Catalogue Number: DIU225U205
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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