MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Implanted: na.Explanted: na.Device evaluation: the lens was returned in liquid in lens vial.Visual inspection found a tear in one haptic.Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a collamer single piece lens, +17.5 diopter, was found to be damaged in the lens vial.The vial was opened but the lens was not removed or used and there was no patient contact.There was a problem with the patients capsule so the surgeon decided not to use the lens.The reporter indicated they were not aware the lens was damaged and were unable to provide any additional information.

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9282376
• Report Number: 2023826-2019-02071
• Device Sequence Number: 336245
• Product Code: HQL
• UDI-Device Identifier: 00841542102346
• UDI-Public: 00841542102346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 02/29/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1