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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
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.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a cc4204a collamer single piece lens, +14.5 diopter, but the lens slipped out of the incision when the surgeon removed the injector.Another same model lens was implanted with no problems.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with moisture on the lens.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: 11231242
• Report Number: 2023826-2021-00191
• Device Sequence Number: 11570406
• Product Code: HQL
• UDI-Device Identifier: 00841542102285
• UDI-Public: 00841542102285
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 03/31/2021
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1