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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
A cq2015a collamer three piece lens, +22.0 diopter, was received by the manufacturer damaged.The reporter indicated the lens was opened and not used.There was no patient contact or injury.They decided to use a different model lens prior to insertion.The reporter indicated the cause of the lens damage was unknown.
Additional Manufacturer Narrative
Additional data: h3: device evaluation: the lens was returned in liquid in lens vial.Visual inspection found the lens optic torn into two pieces.Corrected data: d10: device available for evaluation/returned to manufacturer: (b)(6) 2020.Claim # (b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10075038
• Report Number: 2023826-2020-01090
• Device Sequence Number: 2917277
• Product Code: HQL
• UDI-Device Identifier: 00841542102025
• UDI-Public: 00841542102025
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 09/30/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1