MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number CC4204A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a cc4204a collamer single piece lens, +22.0 diopter, in the patient's eye on (b)(6) 2018.At the patient's post-op appointment the surgeon noted a crack in the lens optic.The lens was explanted and exchanged on (b)(6) 2018 with a different model lens.There was no patient injury.The reporter stated the cause of the lens damage was unknown.

Manufacturer Narrative

Additional data: device evaluation: the product was returned in liquid, in a lens case/vial.Visual inspection found the lens torn in four pieces.(b)(4).

• Brand Name: SEE H-10
• 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 ; 6263037902
• MDR Report Key: 7364198
• MDR Text Key: 103266456
• Report Number: 2023826-2018-00441
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: 00841542102438
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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 Outcome(s): Required Intervention