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

Model Number	CQ2015A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 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 a cq2015a, +24.50 diopter, intraocular lens was implanted and removed right away because there was a zonular dehiscence.There was no patient injury and the surgeon decided to implant an alcon lens.Cause of event was unknown.The reporter was unable to provide further information.
Additional Manufacturer Narrative
Device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Lens torn into two pieces.(b)(4).
Additional Manufacturer Narrative
Corrected data: pre-existing condition: "zonular dehiscence" not included in the initial mdr.Corrected to "malfunction" in the supplemental mdr#1.(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: 7931635
• Report Number: 2023826-2018-01481
• Device Sequence Number: 1722315
• Product Code: HQL
• UDI-Device Identifier: 00841542102070
• UDI-Public: 00841542102070
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2018

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: 06/30/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 12/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/19/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1