MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No additional similar complaint type events within associated lots were found.(b)(4).This is a resubmission of the initial mdr per fda request.
Event or Problem Description
The reporter indicated during surgery, the surgeon tried to implant a cc4204a single-piece collamer lens - +19.0 diopter.The lens would not advance out of the asico cartridge and eventually was torn.

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker street; monrovia, ca
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker street; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 30379022370
• MDR Report Key: 6324408
• Report Number: 2023826-2016-01303
• Device Sequence Number: 11407424
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: (01)00841542102377(17)180228
• Combination Product (Y/N): N
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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 Expiration Date: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: 08/25/2016
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 02/10/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown