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

Model Number	CQ2015A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unk.Collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (b)(4).Claim # (b)(4).This is a resubmission of the initial mdr per fda request.
Event or Problem Description
The reporter indicated the surgeon implanted a cq2015a three-piece implantable collamer lens, +25.0 diopter, in the patient's eye on (b)(6) 2016.The lens was explanted on (b)(6) 2016 because of a lens tear.The reporter stated that the lens did not load correctly.There is no additional information at this time.

• 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: 6138939
• Report Number: 2023826-2016-01305
• Device Sequence Number: 2577483
• Product Code: HQL
• UDI-Device Identifier: 00841542102087
• UDI-Public: (01)00841542102087(17)180630
• Combination Product (Y/N): N
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/30/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 12/01/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female