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

Model Number	HOYA ISERT 251 (+20.00 D)
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
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 not returned to the manufacturer; therefore, the product investigation consisted of a review of the production records only.The results are listed below: since the product was not returned for the investigation, product investigation could not be performed.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.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
When preparing the lens, filled up with healon 10mg/ml; it looked normal.When trying to insert the lens, noticed the trailing haptic wasn´t folded correctly.They had to remove the lens from the incision and open up and repeat with a new lens.

• 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: 8558517
• Report Number: 3006723646-2019-00026
• Device Sequence Number: 11377152
• Product Code: HQL
• UDI-Device Identifier: 04547480480787
• UDI-Public: 04547480480787
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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 251 (+20.00 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 04/26/2019
• 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