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

Model Number	CQ2015A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens device evaluation: the lens was returned in liquid in vial.Visual inspection found the lens optic torn/cut into two pieces.Work order search: another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a cq2015a collamer three piece lens, +17.0 diopter, was inserted and removed from the patients left eye (os), during the same surgery due to the surgeon was unable to get the 2nd haptic to go into the sulcus.The lens was cut into 2 pieces to remove with no patient injury.A 2nd lens was inserted but the surgeon was unable to get the 2nd haptic to go into the sulcus - see mfr report # 2023826-2019-01749 for 2nd lens.A 3rd collamer three piece lens was implanted successfully and the problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
Work order search: one additional complaint type event within associated lots was found.Claim# (b)(4).
Additional Manufacturer Narrative
(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: 9126527
• Report Number: 2023826-2019-01748
• Device Sequence Number: 2820077
• Product Code: HQL
• UDI-Device Identifier: 00841542101929
• UDI-Public: 00841542101929
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 12/11/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/25/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR