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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a cc4204a, +24.50 diopter, intraocular lens was implanted, removed and replaced with the backup lens within the same surgery due to it tearing at fold line.
Additional Manufacturer Narrative
Additional data: device evaluation: lens was returned dry, in a specimen cup.There was clear surgical residue on product.Visual inspection found presence of residue on lens, and lens was returned in pieces-unable to evaluate.(b)(4).
Additional Manufacturer Narrative
Corrected data: (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: 7895683
• Report Number: 2023826-2018-01430
• Device Sequence Number: 13930609
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: 00841542102483
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

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: 02/29/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 12/06/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1