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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: 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, +18.50 diopter, intraocular lens tore during loading.There was no patient contact with the device and a back-up lens was implanted successfully.Cause of event was unknown.
Additional Manufacturer Narrative
Device evaluation : lens was returned in liquid, in lens vial.Visual inspection found the optic and haptic torn.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: d10 - device available for evaluation: returned to manufacturer date, 05-nov-2019 should be corrected to 28-oct-2019.Claim#: (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: 9313024
• Report Number: 2023826-2019-02159
• Device Sequence Number: 460141
• Product Code: HQL
• UDI-Device Identifier: 00841542102360
• UDI-Public: 00841542102360
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 10/15/2019

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 01/16/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/12/2019; 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1