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

Model Number	HOYA ISERT 250 (+24.50 D)
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted after the initial 30-day reporting period deadline; it is part of a corrective action being implemented per internal document capa-(b)(4) for outside us like products reporting.This initial and final emdr is being submitted to fda for outside us like products reporting.The device was returned to the manufacturer, and the product investigation was conducted.The results are listed below: the iol was released from the injector.The trailing haptic was torn at the root and it was found at the nozzle of cartridge tip.The torn haptic was stuck between rod and nozzle.There were no abnormalities found on the slider and screw.Trace of lubricant was found inside the injector tip.Review of the production records showed no nonconformities and/or deviation from the specifications.The exact root cause of the tucking failure of trailing haptic cannot be ascertained.Risk analysis 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
Trailing haptic is not folded correctly.Implantation is done - but the haptic breaks off and the lens must be cut and removed.

• 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: 8579810
• Report Number: 3006723646-2019-00030
• Device Sequence Number: 1666677
• Product Code: HQL
• UDI-Device Identifier: 04547480480879
• UDI-Public: 04547480480879
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: 07/31/2020
• Device Model Number: HOYA ISERT 250 (+24.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 05/03/2019
• 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