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

Model Number CQ2015A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Lens was returned in liquid, in lens vial.Visual inspection found the optic torn/split.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a cq2015a, +16.5 diopter, intraocular lens tore during loading.There was no patient contact and the back up lens was implanted.The reporter stated that the cause of event was unknown.

Manufacturer Narrative

Corrected data: device evaluation: visual inspection found the haptic torn, in the initial mdr.Claim# (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: 7555302
• MDR Text Key: 109623772
• Report Number: 2023826-2018-00810
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542101912
• UDI-Public: 00841542101912
• 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
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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
• Patient Age: 70 YR