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

Model Number	HOYA 250 (+9.50 D)
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial and final emdr is being submitted to fda for outside us like products reporting."error of predicted refractive power" is indicated as a potential adverse event related to iol implantation as noted in the ifu warnings section.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); model: 250).Review of manufacturing records of the product showed there were not any nonconformities and deviations from the specifications.In addition, research in our complaint database indicated there were not any similar events in the same production lot number.(pt20002439) in our manufacturing process, we conduct power check by machine for all iols.The power check is conducted per production lot within the same power to prevent the cross contamination on iol power.The power of the iol is automatically measured by the machine, and if the optical properties is not within our specification, we record the result and discard the iol to prevent contamination of failed iol.We confirmed that the iol was manufactured following validated procedure, and there were not any deviations during manufacturing process and there were not any abnormalities on the specification of the iol.There was no possibility of mix-up with other lens.From our investigation, we couldn't confirm the reported event.Therefore, 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) 2021.Error of predicted refractive; unexpectedly low visual acuity.Suspected wrong power lens.Product remained in eye after clinical assessment.

• 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: 12294907
• Report Number: 3006723646-2021-00059
• Device Sequence Number: 11884681
• Product Code: HQL
• UDI-Device Identifier: 04547480480572
• UDI-Public: 04547480480572
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2021

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: 02/28/2023
• Device Model Number: HOYA 250 (+9.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/09/2021
• 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