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

Model Number	CQ2015A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a cq2015a collamer three piece lens, + 13.5 diopter, and the lens turned the wrong way inside the eye.The lens was removed and replaced with the backup lens within the same surgery with no issues.There was no patient injury.The reporter indicated that the cause of the event was most likely due to a loading issue.
Additional Manufacturer Narrative
Conclusion: as per dfu, this lens model is contraindicated for implantations in patients, less than 60 years of age.(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: 6638947
• Report Number: 2023826-2017-00978
• Device Sequence Number: 14458
• Product Code: HQL
• UDI-Device Identifier: 00841542101851
• UDI-Public: (01)00841542101851(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR