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

Model Number	CQ2015A
Medical Device Problem Code	Device Abrasion From Instrument Or Another Object (1387)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens device evaluation: returned product evaluation found no lens in box.Visual inspection found no lens returned for evaluation.Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a cq2015a, +23.5 diopter, three piece collamer lens was implanted and explanted during the same surgery due to a nick in the optic.The nick occurred during the loading process due to the user not using the optimal type of forceps for this type of lens.The reporter stated this was the first time the user was performing a procedure for this type of lens.There was no enlargement of the incision and no sutures needed.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6576005
• Report Number: 2023826-2017-00759
• Device Sequence Number: 699004
• Product Code: HQL
• UDI-Device Identifier: 00841542102056
• UDI-Public: (01)00841542102056(17)180831
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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: Physician
• Device Expiration Date: 08/31/2018
• 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: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/18/2017
• 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 AND LOT NUMBER - UNK; INJECTOR MODEL AND LOT NUMBER - UNK