MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable, lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
A female patient reported of experiencing flashes of light and floaters after the cataract surgery.After a 10-day follow up, she noticed that she can not see well or drive.The patient's vision is still blurry and distorted.The patient has issues with low light and during cloudy days or at night time, she can see the signs but is not able to see the writing on them.The colors are brighter/bolder, but even during the day the patient has lots of glare.The patient uses over the counter readers 1.5 which are ok but even with readers she is not happy and does not feel the vision in eyes are balanced.The patient has natural lens in her left eye as there is no cataract issue with that eye.The patient would like to drive at night but she is not able to do so as a result of her symptoms.The patient's doctor can not understand why the patient is having issues as they checked the calculations which are fine and even without correction the patient's vision is 20/20 -2, plano -1, axis 115, with refraction 20/15.The trial frame or glasses did not work for the patient although the results showed no significant issues.It was indicted that the patient seems to be very sensitive.The doctor has indicated that the lens is in good position and axis wise it is fine.The doctor does not recommend and does not want to go back in to perform an explant on the patient.It was indicated that the eyes maybe unbalanced as the other eye which also has astigmatism issues has not yet been implanted.It was stated that there is a little bit of astigmatism -1 left in the right eye which may be why it is a little bit off.The doctor has suggested that after 90 days the patient can be prescribed with contact lenses to use over her implanted lens which is going to improve the distance vision as the patient used to use gas permeable lenses before.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11092214
• Report Number: 9614546-2020-00543
• Device Sequence Number: 836904
• Product Code: HQL
• UDI-Device Identifier: 05050474552609
• UDI-Public: (01)05050474552609(17)221108
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: Health Professional
• Device Expiration Date: 11/08/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/29/2020
• 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: Other