MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 230; INTRAOCULAR LENS

Model Number	ISERT 230 (+17.00D)
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This issue is considered mdr reportable as the trailing haptic broke off as lens was being implanted.Surgery technician stated that the surgeon needed to enlarge the incision for removal of the iol.No injury to the patient during or after explant was reported.(serial no.: (b)(4).Regarding the report, customer has indicated that they intend to return the product.Return is pending.Once received, a product investigation will be conducted.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
The trailing haptic broke off as lens was being implanted.Surgery technician stated that the surgeon needed to enlarge the incision in order to remove the iol.No injury to the patient during or after explant.
Additional Manufacturer Narrative
The purpose of this follow-up report #1 is to provide additional information regarding device evaluation findings after the initial report was filed.The device evaluation was conducted by hoya qa (b)(4).Device evaluation details: upon evaluation, only the lens was received from the customer.The lens was ejected out from the injector.One of the haptics was broken at root of the optic/haptic junction.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.(serial no.: (b)(4) -model 230.
Event or Problem Description
The trailing haptic broke off as lens was being implanted.Surgery technician stated that the surgeon needed to enlarge the incision in order to remove the iol.No injury to the patient during or after explant.

• Brand Name: HOYA ISERT 230
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5413022
• Report Number: 3006723646-2016-00002
• Device Sequence Number: 508170
• Product Code: HQL
• UDI-Device Identifier: 04547480301259
• UDI-Public: 04547480301259
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Followup
• Report Date (Section B): 01/26/2016

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 Date: 11/30/2018
• Device Model Number: ISERT 230 (+17.00D)
• Device Lot Number: AK988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2016
• Supplement Report FDA Received Date: 02/17/2016
• 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: 83 YR