MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	ISERT 250 (+22.00 OD)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is pending.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
Report stated posterior capsule rupture that occurred right after iol implantation.Patient prognosis is reported as good, and the surgeon did not need to enlarge the incision to remove the iol.
Additional Manufacturer Narrative
Complaint evaluation details from (b)(4) - the lens was stuck inside the injector tip.The leading haptic was torn.The leading and the trailing haptic were untucked.The cartridge tip was cracked.The slider and the rod could not advance.Trace of lubricant was found inside the injector tip and on the lens.No abnormalities were found in production and inspection records of the product.Root cause was not determined.(serial no.(b)(4) - model 250).
Event or Problem Description
Report stated posterior capsule rupture that occurred right after iol implantation.Patient prognosis is reported as good, and the surgeon did not need to enlarge the incision to remove the iol.

• 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 Key: 5548107
• Report Number: 3006723646-2016-00011
• Device Sequence Number: 191811
• Product Code: HQL
• UDI-Device Identifier: 04547480480824
• UDI-Public: 04547480480824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2016

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 Date: 11/30/2018
• Device Model Number: ISERT 250 (+22.00 OD)
• Device Lot Number: AKA59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 04/12/2016
• 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
• Patient Age: 81 YR