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

Model Number	CQ2015A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: lens was returned in liquid, in lens vial.Visual inspection of the lens found the lens cut in two pieces and the optic torn.Claim# (b)(4).
Event or Problem Description
A cq2015a collamer three piece lens,+22.5 diopter, was returned cut in two pieces.Reporter stated that the wrong lens was open and was not sure if there was any patient contact.
Additional Manufacturer Narrative
The reporter indicated that cq2015a collamer three piece lens, +22.5 diopter, was inserted into the patient's eye on (b)(6) 2017.The reporter indicated the reason for lens return is "wrong lens opened for sulcus" and that there was no injury to the patient.(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: 6564629
• Report Number: 2023826-2017-00800
• Device Sequence Number: 16176520
• Product Code: HQL
• UDI-Device Identifier: 00841542102032
• UDI-Public: (01)00841542102032(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR