MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 230; INTRAOCULAR LENS

Model Number	HOYA 230 (+20.00 D)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable adverse event that occurred in the usa.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
Event or Problem Description
Post-operative complications.Patient complained of blurred vision 3 weeks after implantation.Original implant date was (b)(6) 2021.The original procedure was not complicated in any way and the orientation of the lens was not changed.The lens was exchanged on (b)(6) 2021 for 18.0 diopter power.The lens exchange was caused by the patient wanting better distance vision.The outcome is good.
Additional Manufacturer Narrative
This follow-up #2 emdr is being submitted to fda for a reportable adverse event that occurred in the usa.The report includes additional information not available/included in the initial and follow-up #1 reports.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The product has not been returned as of (b)(6) 2021.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 230).In addition, research in our complaint database indicated there were not any similar complaints for the same production lot numbers.From the available information, 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
Post-operative complications.Patient complained of blurred vision 3 weeks after implantation.Original implant date was (b)(6) 2021.The original procedure was not complicated in any way and the orientation of the lens was not changed.The lens was exchanged on (b)(6) 2021 for 18.0 diopter power.The lens exchange was caused by the patient wanting better distance vision.The outcome is good.12-apr-2021: additional information received from customer: as noted below: the surgeon does not believe this is device related.The iol exchange occurred because the patient wanted better distance vision, so they explanted and exchanged for a different diopter.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable adverse event that occurred in the usa.The report includes corrected / additional information not available / included in the initial report as noted below.B5 - complaint description - corrected to add follow-up information received on 12-apr-2021 that: the surgeon does not believe this is device related.The iol exchange occurred because the patient wanted better distance vision, so they explanted and exchanged for a different diopter.Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, an additional follow-up #2 report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
Event or Problem Description
Post-operative complications.Patient complained of blurred vision 3 weeks after implantation.Original implant date was (b)(6) 2021.The original procedure was not complicated in any way and the orientation of the lens was not changed.The lens was exchanged on (b)(6) 2021 for 18.0 diopter power.The lens exchange was caused by the patient wanting better distance vision.The outcome is good.12-apr-2021: additional information received from customer - as noted below: the surgeon does not believe this is device related.The iol exchange occurred because the patient wanted better distance vision, so they explanted and exchanged for a different diopter.
Event or Problem Description
Post-operative complications.Patient complained of blurred vision 3 weeks after implantation.Original implant date was (b)(6) 2021.The original procedure was not complicated in any way and the orientation of the lens was not changed.The lens was exchanged on (b)(6) 2021 for 18.0 diopter power.The lens exchange was caused by the patient wanting better distance vision.The outcome is good.12-apr-2021: additional information received from customer: as noted below: the surgeon does not believe this is device related.The iol exchange occurred because the patient wanted better distance vision, so they explanted and exchanged for a different diopter.
Additional Manufacturer Narrative
This follow-up #3 emdr is being submitted to fda for a reportable adverse event that occurred in the usa.The report includes corrected information and additional information not available/included in the initial and follow-up #1 and #2 reports.Corrected information: d9 - device available for evaluation - corrected to yes.H3 - device evaluated by manufacturer: - corrected to yes.Additional information: g6 - type of report - noted as follow-up #3.The product was returned to the manufacturer.The investigation was reviewed, as noted below.The product was returned as of 25 may 2021.The physical unit (lens only) was received on 25-may-2021.Iol was cut into 2 pieces for explantation.The investigation results will not be changed as we agreed with the surgeon's assessment that this case was not related to product quality.

• Brand Name: HOYA ISERT 230
• 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: 11611345
• Report Number: 3006723646-2021-00022
• Device Sequence Number: 3086287
• Product Code: HQL
• UDI-Device Identifier: 04547480301310
• UDI-Public: 04547480301310
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 10/31/2022
• Device Model Number: HOYA 230 (+20.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 05/14/2021; 05/14/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/28/2021; 05/17/2021; 06/24/2021
• 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; Required Intervention