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

Model Number	CC4204A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Explanted: unk.Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a cc4204a collamer single piece lens, +10.5 diopter, was removed from the patient's left eye (os).Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Corrected to adverse event in initial mdr.Corrected to required intervention to prevent permanent impairment/damage in initial mdr.Corrected to serious injury in initial mdr.Patient code 2692 corrected to patient code 3191 (secondary surgical intervention, explant) in initial mdr.Device code 3189 corrected to device code 2993 in initial mdr.Method code 4111 should have been included in initial mdr claim# (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: 9136863
• Report Number: 2023826-2019-01817
• Device Sequence Number: 3122843
• Product Code: HQL
• UDI-Device Identifier: 00841542102209
• UDI-Public: 00841542102209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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