MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW150
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.Ethnicity: unknown, information not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted if explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that while inserting a dfw150 model intraocular lens (iol) into patient's left eye, the lens came out of the cartridge before it was completely in the eye which caused the lens to be halfway out of the cartridge and could not reload it.The procedure was completed successfully using backup lens of same model and diopter.There was no patient injury and no medical/ surgical interventions were done.Patient was doing good at the time of discharge.No further information available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: 11/11/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification, of the cartridge, revealed viscoelastic residue on the inside of the cartridge.Further inspection revealed that the lens was stuck in the cartridge.The lens was removed from the cartridge; however, during the removal process foreign matter was observed inside of the lens module.The lens was inspected under magnification as well, revealing lens damage.The complaint issue could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed 1 similar complaint was received for this production order number, based on the investigation results, no escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12573845
• Report Number: 2020664-2021-07616
• Device Sequence Number: 1101247
• Product Code: MFK
• UDI-Device Identifier: 05050474751316
• UDI-Public: (01)05050474751316(17)240413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: 04/13/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: Female
• Patient Race: White