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

Model Number	CC4204A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid in the lens case/vial.There was dark residue on the lens.Visual inspection found a piece of the haptic missing.No similar complaint type events reported for units within the same lot.
Event or Problem Description
On (b)(6) 2017, after reviewing a returned lens, it was determined that a product malfunction may have occurred.The lens box states, "not used; tear." claimant states to have no additional information regarding this lens.Associated lens is a cc4204a, diopter +25.0.
Additional Manufacturer Narrative
Corrected data: date of event: corrected from unk to (b)(6) 2017.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: 7152520
• Report Number: 2023826-2017-01968
• Device Sequence Number: 16373108
• Product Code: HQL
• UDI-Device Identifier: 00841542102490
• UDI-Public: 00841542102490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 03/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1