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)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.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 c4204a, +22.5 diopter, intraocular lens "was loaded incorrectly, inserted and removed." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: b5 - cc4204a +22.5 diopter, intraocular lens "was loaded incorrectly, inserted and removed" from the patient's right eye (od).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: 9416951
• Report Number: 2023826-2019-02294
• Device Sequence Number: 13586657
• Product Code: HQL
• UDI-Device Identifier: 00841542102445
• UDI-Public: 00841542102445
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 09/30/2020
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR