MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	HOYA ISERT 250 (+23.00 D)
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting.Manufacturer's codes for patient health effects (clinical and impact), and device problem and component have been entered in this report.Manufacturer's codes for investigation type, findings and conclusion are pending the completion of the product investigation.Once the investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for investigation type, findings and conclusion.
Event or Problem Description
Packaging problem; there is unknown debris at opening pouch.No patient involvement.The event occurred in (b)(6).There was no impact to the patient, however it was reported to the (b)(6) by the hospital.
Event or Problem Description
Packaging problem; there is unknown debris at opening pouch.No patient involvement the event occurred in china.There was no impact to the patient, however it was reported to the chinese authority by the hospital.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - device evaluated: corrected to yes additional information: d9 - added date returned product was received by manufacturer g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for correction and additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The appearance check result was not consistent with the reported information.No foreign matter or unknown debris was found on the product or in the returned pouch.Therefore, we were not able to confirm the reported event.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 250).In addition, research in our complaint database indicated there were not any similar complaints in the same production lot.The exact root cause was not determined.However, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 12136909
• Report Number: 3006723646-2021-00052
• Device Sequence Number: 3357166
• Product Code: HQL
• UDI-Device Identifier: 04547480480848
• UDI-Public: 04547480480848
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 12/31/2023
• Device Model Number: HOYA ISERT 250 (+23.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1