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

Model Number	ISERT 230 (+18.00D)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	12/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This issue has been designated as "broken haptic, a malfunction of the device and is considered mdr reportable, as serious injury was reported by surgery center.Product evaluation revealed that the trailing haptic was broken at the root of the optic/haptic junction.The broken haptic remained inside the injector tip.The screw and the rod was advanced partially.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 230.Internal reference: (b)(4).
Event or Problem Description
The trailing haptic detached from lens and stood inside of cartridge.The incision was not enlarged for the explant.The doctor cut the lens in half to remove the lens from the eye and replaced damaged lens with a 2nd hoya lens.The 2nd hoya lens was implanted without difficulty.Additional information reported "significant corneal edema due to lens removal resulting in serious injury." patient prognosis was reported as ok.

• 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: 5406828
• Report Number: 3006723646-2016-00001
• Device Sequence Number: 621375
• Product Code: HQL
• UDI-Device Identifier: 04547480301273
• UDI-Public: 04547480301273
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/12/2016

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: 02/28/2017
• Device Model Number: ISERT 230 (+18.00D)
• Device Lot Number: AJ196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2016
• 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: 69 YR