MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	AQ5010V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter: -02.00.Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Method: evaluation method: lens work order search.Evaluation results: a lens work order search revealed no similar complaint within the work order.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).
Event or Problem Description
The reporter stated the surgeon used an aq5010v -02.00 diopter three piece silicone lens.The lens was inserted into the eye.The lens would not fold correctly.The lens was removed and backup lens, same model and size was implanted.The incision was enlarged to remove the lens, no suture required.Reporter stated the lens was defective.
Additional Manufacturer Narrative
Based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).
Additional Manufacturer Narrative
(b)(4).Based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5542954
• Report Number: 2023826-2016-00385
• Device Sequence Number: 895538
• Product Code: HQL
• UDI-Device Identifier: 00841542101318
• UDI-Public: (01)00841542101318(17)200630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2016

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: 06/30/2020
• Device Model Number: AQ5010V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/01/2016
• Supplement Report FDA Received Date: 09/24/2016; 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1