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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a cq2015a collamer three piece lens, +25.5 diopter, from the patient's eye due to the back haptic was torn off during insertion.The lens was cut out of the eye to remove.The lens was replaced with a different lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated there was no patient injury or enlargement of the incision.H3: device evaluation: the lens (one haptic) was returned stuck in a cartridge.There was no visible damage to the cartridge.Corrected data: h6: patient code - 2692 to 2199.Claim # (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: 9528007
• Report Number: 2023826-2019-02493
• Device Sequence Number: 19506918
• Product Code: HQL
• UDI-Device Identifier: 00841542102094
• UDI-Public: 00841542102094
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 09/30/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL CQ CARTRIDGE - LOT # 1451489; INJECTOR MODEL MSI-TM - LOT # UNK
• Patient Age: 63 YR