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

Model Number	HOYA ISERT 251 (+16.00 D)
Medical Device Problem Codes	Break (1069); Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
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 lens was ejected out from the injector tip.One of the haptics was torn at blue pmma tip.The slider was not slightly advanced until it's stopped.The screw could advance fully.Cracked line was observed at the tip.Trace of lubricant was found inside the cartridge tip.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
The lens injector was correctly prepared & handed over to the surgeon; but as soon as the iol was carefully injected into the capsular bag, the surgeon verbalized that the trailing haptic is somehow stuck on the rod tip as he can't release the trailing haptic completely from tip.There was also resistance when he attempted to pull out the injector from the incision, and in the end the trailing haptic was detached from the optic; thus, he had to make a bigger incision in order to remove the iol that was already inside the capsular bag.We have to open and reload a new lens, but this time it went in smoothly without any issues; then, he needed to suture the incision just to make sure the eye won't leak.

• 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: 8579843
• Report Number: 3006723646-2019-00033
• Device Sequence Number: 11147297
• Product Code: HQL
• UDI-Device Identifier: 04547480450216
• UDI-Public: 04547480450216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/09/2018

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: 11/30/2019
• Device Model Number: HOYA ISERT 251 (+16.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• 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