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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Corneal Edema (1791); Blurred Vision (2137); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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).
Additional 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
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6745615
• Report Number: 2023826-2017-01241
• Device Sequence Number: 856157
• Product Code: HQL
• UDI-Device Identifier: 00841542102469
• UDI-Public: 00841542102469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 08/08/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/04/2017; 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR