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

Model Number CC4204A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791); Blurred Vision (2137); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon inserted and removed a cc4204a collamer single piece lens, +23.5 diopter, within the same surgery.The incision was enlarged to remove the lens and a vitrectomy was performed.The lens was not exchanged for another lens.The reporter indicated the lens was torn.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

The surgeon reported for the corneal edema there was standard post-operative antibiotic and anti-inflammatory drops used.There was no post-op inflammation.Patient's current condition, as of last visit on (b)(6) 2017, not well; she is 2 months out from the surgery with persistent corneal edema and reduced visual acuity of 20/150.There was no lens or injection system returned.(b)(4).

Manufacturer Narrative

Additional information received - the customer reported the cc4204a collamer single piece lens, was inserted and the lens optic was noted to be broken.Upon removal of the lens, the posterior capsule was torn.There was patient injury - corneal edema, blurry vision and corneal decompensation.An anterior chamber lens was implanted.The customer reported loading the iol caused a fracture of the optic and the cause of the event was the injection system.The patient's current condition is - bcva - 20/150, poor vision, photophobia, foreign body sensation and floaters.Conclusion code: (the collamer single piece iol is generally indicated for primary implantation for the visual correction of aphakia in persons 60 year of age or older in whom a cataractous lens has been removed by cataract extraction.This patient was (b)(6) years old).(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6745615
• MDR Text Key: 81111465
• Report Number: 2023826-2017-01241
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102469
• UDI-Public: 00841542102469
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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
• Patient Age: 56 YR