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

Model Number CQ2015A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens the lens was returned in liquid, in lens case/vial.Visual inspection found the lens optic torn and one haptic bent.(b)(4).

Event Description

The reporter indicated there was a loading issue with a cq2015a collamer three piece lens, +20.0 diopter.There was patient contact but no injury noted.The backup lens was implanted.The reporter indicated the surgeon used a competitor's injection system.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Work order search: no similar complaint type events were reported for units within the same lot.Corrected data: claim# (b)(4).

Manufacturer Narrative

Corrected data: device evaluation: visual inspection found the lens optic and haptic torn; haptic bent.Claim# (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: 7594343
• MDR Text Key: 110867223
• Report Number: 2023826-2018-00873
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542101981
• UDI-Public: 00841542101981
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 08/13/2018
• Supplement Dates FDA Received: 07/24/2018; 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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: 89 YR