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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS
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HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS Back to Search Results
Model Number ISERT 250 (+19.00 OD)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/09/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation details: the product was not returned.Result of investigation revealed no abnormalities were found in production and inspection records of the product.The exact root cause was not ascertained.Serial # (b)(4) - model 250.
 
Event or Problem Description
The leading haptic broke in half.The surgeon needed to enlarge the incision to remove the iol from the patient's eye.Patient prognosis is reported as good.
 
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Brand Name
HOYA ISERT 250
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
HOYA SURGICAL OPTICS, INC.
14768 pipeline avenue
chino hills CA 91709
MDR Report Key5519829
Report Number3006723646-2016-00009
Device Sequence Number18931311
Product Code HQL
UDI-Device Identifier04547480480763
UDI-Public04547480480763
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P080004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/23/2016
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 Date11/30/2018
Device Model NumberISERT 250 (+19.00 OD)
Device Lot NumberAKA46
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2016
Initial Report FDA Received Date03/23/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age82 YR
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