MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; 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	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex, weight, ethnicity, race: unk.Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.The lens was returned in liquid, in a lens vial.Visual inspection found the optic was torn.Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that while injecting a cq2015a intraocular lens, diopter +21.0 into the patient's right (od) eye, the lens tore.Reportedly, the lens was implanted and removed intraoperatively.The reporter states that two lenses were attempted to be implanted into the same eye, the 3rd was implanted successfully.The scrub nurse loaded the 1st two lenses that tore during insertion.Another person loaded the 3rd lens which was successfully implanted.Possible loading error.Reference mfr report# 2023826-2019-02059 for additional torn lens.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9279664
• Report Number: 2023826-2019-02058
• Device Sequence Number: 2388886
• Product Code: HQL
• UDI-Device Identifier: 00841542102001
• UDI-Public: 00841542102001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 11/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR