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	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a cc4204a collamer single piece lens, +20.0 diopter, was noted to be torn by the technician while loading and there was no patient contact.A backup lens was implanted.The reporter was unable to report any additional information.
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry, in lens vial, with residue on lens.Visual inspection found no visible damage to the lens.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: 8871960
• Report Number: 2023826-2019-01385
• Device Sequence Number: 3011909
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: 00841542102391
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 12/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1