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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated a cc4204a collamer single piece lens, +19.5 diopter, could not be loaded and there was no patient contact.The reporter indicated it was unknown if the lens was damaged.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a lens vial in a plastic ziploc bag.Visual inspection found the haptic torn.Claim#: (b)(4).

• 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: 8011759
• Report Number: 2023826-2018-01570
• Device Sequence Number: 1525294
• Product Code: HQL
• UDI-Device Identifier: 00841542102384
• UDI-Public: 00841542102384
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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: 09/30/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1