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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned dry, loose in the box.There was clear surgical residue on the product and lens surface.Visual inspection found the optic torn.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the cq2015a intraocular lens, diopter +23.0 was being injected into the patient's left (os) eye, the haptic broke inside of the lens inserter.Reportedly, this was due to the lens being "misloaded by the tech." the lens was explanted intraoperatively.This occurred on (b)(6) 2018.
Additional Manufacturer Narrative
Additional data: the lens was removed and exchanged with a backup lens intraoperatively on (b)(6) 2018.Corrected data: return date is corrected to 23-aug-2018.Device evaluation: visual inspection found the optic torn along with the haptic torn.(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: 7906884
• Report Number: 2023826-2018-01327
• Device Sequence Number: 19284388
• Product Code: HQL
• UDI-Device Identifier: 00841542102049
• UDI-Public: 00841542102049
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 12/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR