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

Model Number AQ5010V

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791); Macular Edema (1822); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide).(b)(4).

Event Description

The reporter indicated an aq5010v silicone three piece lens, +1.0 diopter, was implanted by another surgeon on (b)(6) 2019 as a piggy-back lens.The reporter indicated the aq5010v lens was explanted on (b)(6) 2020 by a different surgeon (facility), due to the primary lens had decentered and the haptic of the aq5010v had folded back.The lens was discarded.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

B5: the piggyback iol was slightly decentered and one haptic was folded back on iol, which resulted in cme, corneal decompensation and corneal edema in right eye (od).Iol exchange and dsaek were performed.The reporter indicated the cause of the event was due to the placement of iol.The piggyback iol was placed behind the primary lens, was compressed within the bag and haptic was folded back on the iol.Post-op medication was prescribed.Post-op, patient reported vision is blurry but improving every day.H6: health effect impact code: 4625 - iol exchange and dsaek performed.Claim # (b)(4).

• Brand Name: SEE H-10
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11119663
• MDR Text Key: 225305222
• Report Number: 2023826-2021-00001
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P880091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: AQ5010V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention