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

Model Number	DIU375
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: not applicable as there was no patient contact with the device.Section a-3a patient sex: not applicable as there was no patient contact with the device.Section a-3b patient gender: not applicable as there was no patient contact with the device.Section a-4 patient weight: not applicable as there was no patient contact with the device.Section a-5 patient ethnicity: not applicable as there was no patient contact with the device.Section a-6 patient race: not applicable as there was no patient contact with the device.Section d-6a date implanted: not applicable as there was no patient contact with the device.Section d-6b date explanted: not applicable as there was no patient contact with the device; therefore, not explanted.Section h-3 device evaluated by manufacturer: 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 report will be filed.An attempt was made to contact the customer account requesting additional information regarding complaint 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
During product handling the pre-loaded diu375 model intraocular lens (iol) was reported to have looked hazy and it had a spot on it.There was no patient contact with the iol.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes section d-9: device date returned to manufacturer: 13-nov-2024 section h-3: device evaluated by manufacturer: yes device evaluation: a lens was received loose in the complaint box.The complaint handpiece was received in a handpiece tray which was in an open sterilization pouch.During a visual inspection, the device was inspected under magnification.The complaint device was received with the plunger rod fully retracted.Viscoelastic residue was not evenly distributed through the length of the cartridge.No cartridge issues were identified.No assembly issues were externally identified.The lens was received coated in viscoelastic residue.The lens was cleaned and presented with no issues.Complaint issue could not be confirmed during product evaluation, and no issues were identified.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.A search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number ¿ stuck in cartridge and override.These complaint issues reported are not related.Based on complaint history review (chr) results, no further actions are required.Conclusion: based on the complaint investigation results, the product was released within specifications and the complaint issue reported could not be confirmed.No product deficiency or product malfunction was 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: 20595830
• Report Number: 3012236936-2024-000294
• Device Sequence Number: 15689291
• Product Code: MJP
• UDI-Device Identifier: 05050474748019
• UDI-Public: (01)05050474748019(17)270508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: DIU375
• Device Catalogue Number: DIU375U050
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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