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

Model Number	CQ2015A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon noticed torn/broken haptic on a cq2015a, +18.0 diopter, intraocular lens during loading.There no patient contact.Back up lens was implanted during initial surgery, problem resolved.The reporter indicated that the surgeon did not say what he believed to be the cause.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a lens case,vial.Visual inspection found the haptic torn.(b)(4).
Additional Manufacturer Narrative
Corrected data: "the reporter indicated that the surgeon did not say what he believed to be the cause." should be corrected to "in the opinion of the surgeon the stated cause of the event was "technical error." in the inital mdr.(b)(4).
Additional Manufacturer Narrative
Additional information: (b)(6) 2019 should be added to the initial mdr.Corrected data: "in the opinion of the surgeon the stated cause of event was "technical error." should be corrected to "the cause of the event is unknown." in the previous mdr.(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8699726
• Report Number: 2023826-2019-01054
• Device Sequence Number: 2168549
• Product Code: HQL
• UDI-Device Identifier: 00841542101943
• UDI-Public: 00841542101943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2019

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 08/28/2019; 09/25/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/27/2019; 09/04/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1