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

Model Number	CQ2015A +23.5
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.One similar complaint type event was reported for units within the same lot.Lens was returned in liquid, in lens vial.Visual inspection found that the haptic was bent.(b)(4).
Event or Problem Description
The reporter stated "cq2015a was loaded into the cq cartridge, appeared to have the trailing haptic look kinked.Iol was delivered onto sterile table and the trailing haptic was kinked.It appears the msi-tm injector rod was bent in the upward position and that is why the trailing haptic was kinked.We did not have the lot number for the injector and the injector was trashed.No patient contact with product.Iol did not get implanted or touch the patient.No patient injury.We got another msi-tm injector, another cq cartridge and another cq iol and it was successfully implanted".

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8458201
• Report Number: 2023826-2019-00499
• Device Sequence Number: 3057239
• Product Code: HQL
• UDI-Device Identifier: 00841542102056
• UDI-Public: 00841542102056
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 08/31/2020
• Device Model Number: CQ2015A +23.5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1