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

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.(b)(4).No similar complaint types reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon implanted a cq2015a collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens, diopter +20.0 into the patient's eye, the lens tore/broke.Reportedly, when attempting to implant, the leading haptic and part of the optic tore off and stuck in the cartridge.The surgeon needed to enlarge the incision to remove the cartridge.In addition, it is stated that three sutures were used to close the incision.This occurred on (b)(6) 2017.An alternate lens was implanted and the patient is reportedly in stable condition.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6899555
• Report Number: 2023826-2017-01513
• Device Sequence Number: 761105
• Product Code: HQL
• UDI-Device Identifier: 00841542101981
• UDI-Public: 00841542101981
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/27/2017
• 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
• Patient Age: 76 YR