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

Model Number	DXW225
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pre-loaded dxw225 model intraocular lens (iol) was reported to have been fully inserted in the patient's eye however, the iol would not unfold and the haptic was stuck to the cartridge.During the same procedure the suspect iol was removed and replaced with another dxw225 5.0 diopter iol that was implanted in the patient¿s ocular dexter (right eye).There was no patient injury and no medical or surgical intervention were required during the procedure.Patient outcome post-procedure was reported as fine.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female was the answer provided.Section a-4 patient weight: unknown/asked information was not provided.Section a-6 patient race: hispanic was the answer provided.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure; 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.
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: the complaint device was received in a handpiece tray which was in an opened sterilization pouch which was in the original folding carton.A lens was stuck to the outside of the complaint device.Visual inspection under magnification reveals the complaint device was received with the plunger rod fully retracted.Viscoelastic residue was distributed through the length of the cartridge and the cartridge tip/cartridge were damaged.The lens module was inspected and presented with no damage or viscoelastic residue.The device assembly was inspected and presented with no issues.The plunger rod advancement was inspected and presented with no issues.The lens was received coated in viscoelastic residue.The lens was cleaned and presented with no issues.Complaint issues "unfolding issue" and "delivery issue" were 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 and the complaint issues 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: 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: 20595715
• Report Number: 3012236936-2024-000294
• Device Sequence Number: 17781702
• Product Code: HQL
• UDI-Device Identifier: 05050474763852
• UDI-Public: (01)05050474763852(17)260309
• 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): 12/11/2024

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 Expiration Date: 03/09/2026
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U050
• 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: 11/27/2024
• Initial Report FDA Received Date: 11/03/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic