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

Model Number CQ2015A

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

Device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Lens torn into two pieces.(b)(4).

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7931635
• MDR Text Key: 122640384
• Report Number: 2023826-2018-01481
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102070
• UDI-Public: 00841542102070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 12/05/2018
• Supplement Dates FDA Received: 10/19/2018; 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1