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

Model Number	CC4204A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt age and weight: unk.Concomitant product(s): collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a cc4204a collamer single piece lens, +20.0 diopter, but the surgeon did not like the way the lens was laying in the patient's eye, so the lens was removed.The lens was replaced with another lens.There was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter indicated the lens was removed within the same surgery.There was no patient injury, no enlarged incision or sutures.The lens was replaced with another staar lens.The reporter indicated there was no issue with the lens, only the way the lens was positioned in the eye.(b)(4).
Additional Manufacturer Narrative
Correction: (b)(6) 2016.Result code(s): (operational problem) : visual inspection of the returned product found no visible damage to the lens.The lens was returned in a small amount of liquid.Conclusion code(s): (unable to confirm complaint): based on the complaint history, work order search, medical review and product evaluation, a specific root cause of the event could not be determined.(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: 6150076
• Report Number: 2023826-2016-01732
• Device Sequence Number: 13547194
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: (01)00841542102391(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2016

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: 08/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/06/2017; 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Age: 78 YR