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

Model Number ISERT® 250 (+17.50 OD)

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that the haptic of the lens was damaged as lens touched the eye, but the lens was not fully inserted.

Manufacturer Narrative

This mdr supplement is being submitted at this time as an outcome of an internal company audit conducted on product complaint handling.It was discovered that a mdr supplement was not submitted to fda by previous qa/ra personnel, as required.Device evaluation details from qa (b)(4): the lens was found inside at the top of injector tip.Leading hatic was torn at tip and the torn haptic piece was not found.The slider was fully advanced 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.(serial no: (b)(4), model: 250).The exact root cause is not determined.

Event Description

The customer reported that the haptic of the lens was damaged as lens touched the eye, but the lens was not fully inserted.

• Brand Name: HOYA ISERT® ASPERIC INTRAOCULAR LENS 250
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: corina pierson ; 14768 pipeline avenue; chino hills, CA 91709 ; 9096803900
• MDR Report Key: 4777644
• MDR Text Key: 5800419
• Report Number: 3006723646-2015-00409
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: ISERT® 250 (+17.50 OD)
• Device Lot Number: AJ746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention