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 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found the lens torn in two pieces and a tear in the optic.Work order search: no similar complaint type event was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a cq2015a intraocular lens, +19.0 diopter, was damaged during insertion.The lens was removed and the back up lens was implanted within the same surgery with no issues.A staar injection system was used, unable to provide lot numbers.

Manufacturer Narrative

Corrected data: concomitant medical products: cartridge lot number corrected from "unk" to "1390717".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: 7366363
• MDR Text Key: 103529225
• Report Number: 2023826-2018-00458
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542101967
• UDI-Public: 00841542101967
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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: 66 YR