MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number PCB00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Eye Injury (1845); Inflammation (1932); Red Eye(s) (2038); Visual Disturbances (2140); Excessive Tear Production (2235); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity: unknown; requested but not provided.If explanted, give date: not applicable, as the lens remains implanted.The device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).Attempts have been made to obtain missing information; however, the patient did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after the intraocular lens (iol) was implanted in the right eye, the patient (pt) experienced issues immediately.The pt reported seeing fine during the day, but at night sees flashes of lights when driving.The pt described it like carnival ferris wheel lights in the peripheral vision, making the pt dizzy.The pt also experienced dry eye after surgery and began using over the counter lubricating eye drops.The pt reported that three months after surgery, the doctor stated that the lens was wrinkled, and will need time to become unwrinkled and adhere to the eye.As of may 23, 2022, the doctor stated that the lens was in correctly.The doctor recommended lasik around the edges, but stated that it probably would not help.Approximately five months after surgery, the pt experienced red, itchy eyes that were ¿draining.¿ the pt did a teladoc visit and was told it was inflammation and was prescribed prednisolone acetate 1%.No further information was provided.Through follow-up it was learned that the pt is unable to drive at night or perform daily routine activities due to this issue.The pt has waited two years for the issue to resolve and in that time has had to contact the doctor ¿because of inflammation, itching, seeping, etc.¿ the pt saw the doctor recently who advised that the lens was in correctly and there is nothing that can be done.No further information was provided.

Manufacturer Narrative

Additional information: through follow-up with the doctor¿s office, it was reported that on jan 31, 2020, at one day post-op, there was a capsular fold in the right eye (od).On (b)(6) 2020, the slit lamp exam showed posterior capsule (pc) intraocular lens (iol) perfectly centered with clear posterior capsule.There was no mention in the notes of capsular fold at that time.The patient was complaining of ferris wheel effect of light temporal to the right side.The doctor said that it could possibly be the light catching the edge of the lens causing this effect.If this is what was happening, the doctor noted that as the capsule shrank around the lens, that issue should resolve.Visual acuity was 20/40 uncorrected, corrected to 20/25+ with minus ¾ of diopter.The patient had a tele-med visit on apr 22, 2020, complaining of two-week history of itchy, watering eyes.The patient was using over the counter tears (preservative and preservative-free) and over the counter zaditor and a cool compress.The patient was diagnosed with allergic conjunctivitis and ocular allergies and was prescribed topical steroids 3x a day for 5 days, then 1x a day for 5 days.The patient was also prescribed pazeo (prescription allergy drop).In may of 2022 and the patient had trace posterior capsule opacification (pco) peripherally od.The patient was still mentioning the ferris wheel effect visual issue.The patient¿s visual acuity was 20/25+ uncorrected in right eye.The doctor does not believe the pco is contributing to issue at night, as it is peripheral.The doctor did discuss the yag procedure with the patient but did not recommend it.The doctor noted endothelial pigment in the cornea od.The doctor thinks the pigments flecks are likely causing the scattering of light od, however the patient stated that that the visual issue moves.The doctor suggested that the patient see one of the cornea specialists in the practice and a retinal specialist or a neuro-ophthalmologist to rule out any other issues.The patient scheduled a visit to see the corneal specialist later this month but has since canceled it.There are no planned interventions and no scheduled visits.There is no issue with the lens itself.There was nothing out of the ordinary with the cataract surgery from the patient's operative notes, and no issues with lens placement or implantation.As of jul 22, 2022, it was reported that the doctor has not seen the patient since may 2022.No further information was provided.Correction: on initial mdr 3012236936-2022-01611, section h6: medical device problem code 3191 was initially coded to capture the patient¿s report of ¿lens was wrinkled¿, however with the new information provided, it was clarified that the issue was capsular folds (captured as health effect - clinical code 4581 to capture posterior capsular striae/wrinkles).The medical device problem code has been updated to 2993 on this supplemental report.The following sections have been updated accordingly: section h6: health effect - clinical code: 4581 is to capture posterior capsular striae/wrinkles and posterior capsule opacification (pco).Section h6: health effect - clinical code: 1845.Section h6: health effect - clinical code: 2235.Section h6: health effect - clinical code: 1784.Section h6: medical device problem code: 2993.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14739562
• MDR Text Key: 294877019
• Report Number: 3012236936-2022-01611
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558267
• UDI-Public: (01)05050474558267(17)221008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White