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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Capsular Bag Tear (2639)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found the lens torn in three pieces and portion of a haptic missing.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a collamer single piece lens, +24.5 diopter, created posterior capsule rupture without vitreous loss.The posterior rupture was noticed during lens insertion, no vitrectomy was performed since there was no vitreous loss.The reporter stated that there was no patient injury.A different model lens was implanted with no issues.
Additional Manufacturer Narrative
Returned to manufacturer: date was corrected to 23-jun-2017 from 26-jun-2017.(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: 6712661
• Report Number: 2023826-2017-01108
• Device Sequence Number: 16547908
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: (01)00841542102483(17)180831
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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?: No
• 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: 06/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: 80 YR