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

Model Number	CQ2015A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ollamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens device evaluation: the lens was returned in liquid in vial.Visual inspection found the lens haptic torn.The cartridge was returned and there was no visible damage to the device.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a cq2015a collamer three piece lens, +15.5 diopter, and the haptic tore.This is the 2nd lens used for this patient that was damaged and removed.See mfr report # 2023826-2019-01746.A 3rd collamer three piece lens was implanted successfully and 2 sutures were required to close the incision.The cause of the event was user error.At one day post-op, patient was in satisfactory condition.

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9126509
• Report Number: 2023826-2019-01747
• Device Sequence Number: 2597075
• Product Code: HQL
• UDI-Device Identifier: 00841542101899
• UDI-Public: 00841542101899
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention