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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, with the results listed below: the lens was ejected out from the injector and broken into 3 pieces.The optic was broken from root of one haptic.One haptic was torn at root.The slider was advanced backward.The nozzle was cracked.Trace of lubricant was found in the injector.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.From our investigation, we assume this issue is not product related.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
Cracked or broken optic.Noted in surgery room.No patient impact.Event occurred in (b)(6).There was no impact to patient, but it was reported by hospital as ae to (b)(6) authority.

• 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: 8976730
• Report Number: 3006723646-2019-00094
• Device Sequence Number: 16897003
• Product Code: HQL
• UDI-Device Identifier: 04547480480787
• UDI-Public: 04547480480787
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: HOYA ISERT 251(+20.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1