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

Model Number	CQ2015A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three 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 cq2015a, +24.0 diopter, intraocular lens was damaged during the insertion, the optic was torn.There was patient contact but no injury.Cause of damage is unknown.The lens was removed and replaced with the same diopter and model during initial surgery.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a lens vial.The lens was returned in pieces - unable to evaluate.Date received by manufacture: date received should be corrected to 25-sep-2018 in previous mdr.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: 7994772
• Report Number: 2023826-2018-01556
• Device Sequence Number: 1531665
• Product Code: HQL
• UDI-Device Identifier: 00841542102063
• UDI-Public: 00841542102063
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 10/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR