MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt weight - unk.Concomitant product(s): - collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens device evaluation: lens was returned in liquid, in a lens vial.Visual inspection found the optic torn and a missing piece of the optic/haptic.(b)(4).
Event or Problem Description
The reporter stated that when inserting a cc4204a, +22.0 diopter, single piece collamer lens, into the loader, the lens bent over itself and tore when it was advanced.There was no patient contact.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6411217
• Report Number: 2023826-2017-00431
• Device Sequence Number: 538034
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: (01)00841542102438(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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
• Operator of Device: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT # - UNK; INJECTOR MODEL AND LOT # - UNK
• Patient Age: 69 YR