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

Model Number	CQ2015A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.(b)(4).No similar complaint type events were reported for units within the same lot.Device evaluation: lens was returned in vial, in liquid.Visual inspection found optic torn.(b)(4).
Event or Problem Description
The reporter indicated on (b)(6) 2019 a cq2015a, +22.0 diopter, intraocular lens was "miss powered" and the lens was removed.There was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8355687
• Report Number: 2023826-2019-00287
• Device Sequence Number: 1697772
• Product Code: HQL
• UDI-Device Identifier: 00841542102025
• UDI-Public: 00841542102025
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1