MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); No Code Available (3191)
Date of Event	02/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? no - lens not returned.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -6.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, angle closure, pupillary block and elevated intraocular pressure.Additional laser peripheral iridotomies were performed.The reporter indicated they felt there was possible aqueous misdirection.The lens was not exchanged for another lens.The patient's post-op best-corrected visual acuity was 20/20.
Additional Manufacturer Narrative
Result: (operational problem): visual inspection of the returned product found one haptic torn.The lens was returned in liquid and there was evidence of clear surgical residue.(b)(4).
Additional Manufacturer Narrative
Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, product evaluation, medical review and device history record review, work order search, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5668563
• Report Number: 2023826-2016-00735
• Device Sequence Number: 18869243
• Product Code: MTA
• UDI-Device Identifier: 00841542103213
• UDI-Public: (01)00841542103213(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2016

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: 11/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 06/21/2016; 09/13/2016
• 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: 40 YR