MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS ABBOTT TECNIS SYMFON LENSE INTRAOCULAR LENSES

Model Number ZXR00

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Had cataract surgery using abbott labs "tecnis symfony intraocular lens" for which glasses should not be needed.I cannot read without glasses and eyelids constantly itching.I paid dr (b)(6), (b)(6) did the surgery and then several follow ups eye tests which confirmed i can't read without glasses.(b)(6) extra over medicine for this product based on claim glasses not needed.If others having same product lens problem, the lens should be removed.Dr (b)(6), the surgeon, advised me he has not had this problem with the lenses with any of his other many pts who used the lenses.

• Brand Name: ABBOTT TECNIS SYMFON LENSE INTRAOCULAR LENSES
• Type of Device: ABBOTT TECNIS SYMFON LENSE INTRAOCULAR LENSES
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS
• MDR Report Key: 7150587
• MDR Text Key: 96046527
• Report Number: MW5074264
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ZXR00
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 78