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

Model Number	HOYA ISERT 250 (+24.00 D)
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting.Regarding manufacturer's codes for patient and device have been entered.Once device is received and product investigation is completed, a follow-up report will be submitted to fda with the additional manufacturer's codes included.
Event or Problem Description
Incorrect information on label~this is just one possibility.After implanting the 24.00 d.Iol the patient ended up in 4.00 d.Hypercorrection.Biometries before and after surgery are consistent.The lens was explanted.Secondary surgery was done on (b)(6) 2019.A new lens was inserted without any patient harm.After second surgery patient feels good.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for outside us like products reporting.This reporting includes corrected information and additional information not available/included in the initial report, in the following sections: d10: device available? corrected to yes; and added the returned date g7: type of report noted as follow-up #1.H2: noted that this contains "corrected information" and "additional information".H3: device evaluated by manufacturer? corrected to yes.H6: manufacturer's codes added codes for: method; results; and conclusion.The device was returned to the manufacturer, and the product investigation was conducted.The results are noted below: the iol was returned in gauze and some fiber of gauze was found on the iol.There were not any sign of scratches, extraction or deformations on both haptics and optic.The injector and outer box were not returned.We understand from the complaint case details that the returned iol was explanted from the eye 6 months after cataract surgery and returned to us.We checked power in air with nidek lens meter, and found the power is not a match to the manufacturing record.(it was +69.00d in lot traveler, but it was +48.00d in the result of the measurement we conducted.) no abnormalities were found in production and inspection records of the product.(serial no: (b)(6); model: 250).Exact root cause is not determined.From our investigation, we couldn't deny that it is possible that this is not a product related case.Output of the investigation results were communicated to the clinician's office.The clinician office wanted to verify whether the mix up happened in their clinic or caused by the manufacturer.The clinician's office was pleased with the information provided by hoya and communicated to hoya complaints team that the mix up could have happened in their operation room.Risk analysis was conducted on the product line and failure codes 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.
Event or Problem Description
Incorrect information on label~this is just one possibility.After implanting the 24.00 d.Iol the patient ended up in 4.00 d.Hypercorrection.Biometries before and after surgery are consistent.The lens was explanted.Secondary surgery was done on (b)(6) 2019.A new lens was inserted without any patient harm.After second surgery patient feels good.

• 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: 9014663
• Report Number: 3006723646-2019-00097
• Device Sequence Number: 2410961
• Product Code: HQL
• UDI-Device Identifier: 04547480480862
• UDI-Public: 04547480480862
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: HOYA ISERT 250 (+24.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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: Required Intervention