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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS
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HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS Back to Search Results
Model Number HOYA ISERT 251
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/08/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4) - s/n: (b)(4): the product was not returned so visual inspection was not performed and further information could not be provided.According to customer, the capsular bag ruptured during iol insertion.No abnormalities were found in production and inspection records of the product.Root cause was not determined.From the investigation, it is believed this issue is not product related.(b)(4).
 
Event or Problem Description
During implant procedure the capsule collapsed.The surgeon cut out the lens to 3 pieces and sac too.Vitrectomy performed.Patient's current prognosis reported to be stable upon discharge.
 
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Brand Name
HOYA ISERT 251
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
HOYA SURGICAL OPTICS, INC.
15335 fairfield ranch road
suite 250
chino hills CA 91709
MDR Report Key6122556
Report Number3006723646-2016-00023
Device Sequence Number19028671
Product Code HQL
UDI-Device Identifier04547480450391
UDI-Public04547480450391
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 distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/22/2016
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? No
Operator of Device Health Professional
Device Expiration Date05/31/2017
Device Model NumberHOYA ISERT 251
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2016
Initial Report FDA Received Date11/22/2016
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 Age75 YR
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