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

Model Number	CQ2015A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon attempted to implant a cq2015a, three-piece collamer lens, +19.5 diopter on (b)(6) 2016.The lens tore during loading.No patient contact.The reporter did not have additional information regarding the lens.

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker street; monrovia CA 91016
• MDR Report Key: 6030222
• Report Number: 2023826-2016-01439
• Device Sequence Number: 391198
• Product Code: HQL
• UDI-Device Identifier: 00841542101967
• UDI-Public: (01)00841542101967(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/20/2016

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2016
• Initial Report FDA Received Date: 10/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR