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

Model Number	CQ2015A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens the lens was returned in liquid in the lens vial.Visual inspection found clear surgical residue on the product and the optic torn/split.(b)(4).
Event or Problem Description
The reporter indicated that, a cq2015a intraocular lens, diopter +16.5 was "loaded incorrectly and then explanted" from the patient's right (od) eye.This occurred on (b)(6) 2018.Reportedly, no patient injury occurred.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Corrected data: corrected to: "adverse event" diopter corrected to: " +26.0" in the initial mdr corrected to: "(b)(6) 2019" in the initial mdr device evaluation corrected to: lens was returned in liquid, in lens vial.There was clear surgical residue on product.Visual inspection found the lens optic torn and presence of residue on lens surface.Patient code corrected to :"3191 secondary surgical intervention, explant", previous code not applicable.Device code corrected to: "2017" in the initial mdr, previous code not applicable.Conclusion code corrected to : "61" in the initial mdr, previous code not applicable.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8268361
• Report Number: 2023826-2019-00166
• Device Sequence Number: 2288304
• Product Code: HQL
• UDI-Device Identifier: 00841542102100
• UDI-Public: 00841542102100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR