MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Lens was returned in liquid, in lens vial.Visual inspection found the lens in two pieces/split and a tear in the optic.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
It was reported that the surgeon implanted a cq2015a, +19.5 diopter, intraocular lens in the patient's left eye (os) on (b)(6) 2017.During implanation the surgeon noticed the lens was cracked.The lens was removed and replaced with a same model lens, different diopter (20.0d).The reporter stated that there was no patient injury and the surgeon is very satisfied with the replacement.The cause of the event was unknown, reporter was not sure if not enough viscoelastic was used or if it was a technician error.The reporter was not able to provide any additional information.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: date received by manufacturer- corrected from 29-nov-2017 to 10-nov-2017 in the initial mdr.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7097253
• Report Number: 2023826-2017-01811
• Device Sequence Number: 11231393
• Product Code: HQL
• UDI-Device Identifier: 00841542101974
• UDI-Public: 00841542101974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/30/2018; 11/28/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/31/2018; 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR