MAUDE Adverse Event Report: HOYA SURGICAL OPTICS INC. ISYMM ASPHERIC INTRAOCULAR LENS

Model Number FC-60AD

Device Problem Difficult to Insert (1316)

Patient Problem Failure of Implant (1924)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The doctor could not get the lens into the incision.Felt that there was an issue with the lens preventing him from implanting the lens.The lens did touch patients eye but was not implanted into the eye.

• Brand Name: ISYMM ASPHERIC INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS INC.; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD
• Manufacturer Contact: 14768 pipeline avenue; chino hills, CA 91709 ; 9096803900
• MDR Report Key: 4617397
• MDR Text Key: 5594040
• Report Number: 3006723646-2015-00396
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

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: Other
• Device Expiration Date: 08/31/2017
• Device Model Number: FC-60AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR