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

Model Number	CC4204A
Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight - unk.Ethnicity - unk.Race - 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, +22.0 diopter, intraocular lens was implanted into the patient's left eye (os) on (b)(6) 2020."lens was cracked/damaged, but it was unclear if lens was cracked prior to being implanted." no patient injury.Back-up lens was implanted.The lens implanted, removed, and replaced intraoperatively.Cause of the event is reported as technician loading error.
Additional Manufacturer Narrative
Corrected data: device code 1494: off- label use in previous mdr is not applicable.Claim#(b)(4).
Additional Manufacturer Narrative
Additional information: h6-device code 1494: off-label use (over 45yrs of age at date of implant) h6- result code 114 is added based on the product evaluation results in previous mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: lens was returned in vial, in liquid.Visual inspection found optic and haptic torn.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9741508
• Report Number: 2023826-2020-00294
• Device Sequence Number: 2513646
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: 00841542102438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2020

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: 09/30/2021
• 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: 03/04/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 04/27/2020; 05/04/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/06/2020; 04/27/2020; 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR