MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	ISERT 251 (+23.50 D)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting."lens surface reflection" is indicated as a potential malfunction in hoya ifu covered under the warnings section.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, an 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
Implant date: (b)(6) 2020.Flawed optic: optic surface reflection; patient sees the halo effect on the periphery of the optic.Post-operative complications; within 5 days after implantation no inflammation.Lens remains implanted.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable adverse event that occurred outside of the usa.The report includes additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.H3 - device evaluated - noted that device was not returned.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The investigation was conducted, with the methods and results as noted below.The product was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 251).The exact root cause was not determined.However, we believe this event was not caused by our product quality.Risk analysis was conducted on the product line and failure code is noted below.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.
Event or Problem Description
Implant date: (b)(6) 2020.Flawed optic: optic surface reflection; patient sees the halo effect on the periphery of the optic.Post-operative complications; within 5 days after implantation.No inflammation.Lens remains implanted.

• Brand Name: HOYA ISERT 251
• 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: 11335633
• Report Number: 3006723646-2021-00007
• Device Sequence Number: 16812206
• Product Code: HQL
• UDI-Device Identifier: 04547480450360
• UDI-Public: 04547480450360
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: ISERT 251 (+23.50 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other