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

Model Number ZCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Conjunctivitis (1784); Corneal Edema (1791); Dry Eye(s) (1814); Ecchymosis (1818); Macular Edema (1822); Eye Injury (1845); Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Keratitis (1944); Red Eye(s) (2038); Retinal Detachment (2047); Uveitis (2122); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Vitreous Loss (2142); Vitreous Detachment (2445); Capsular Bag Tear (2639); Zonular Dehiscence (2698); Corneal Epithelial Microcysts (4465); Eye Infections (4466); Eye Pain (4467); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: exact age not provided, standard deviation unit of measure of years: 66.1 (7.96).Sex/gender: female 211, male 132.Patient weight: unknown/not provided.Race: american indian or alaska native 1, asian, 3, native hawaiian or other pacific islander 0, black or african american 22, white 311, more than one race 0, unknown or not reported 6.Ethnicity: hispanic or latino 22, not hispanic or latino 320, unknown or not reported 1.Date of event: (b)(6) 2022.The date results posted.Model number: partially known, as the serial number was not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.If implanted; give date: unknown/not provided.If explanted; give date: unknown/not provided.The device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Health effect - impact code: 4625 vitrectomy, 4625 secondary surgical intervention (iris reposition, laser retinopexy, laser vitreolysis, and modified paracentesis).Health effect - clinical code: 4581 posterior capsule opacification (pco).Health effect - clinical code: 4467 ocular discomfort, 4467 pain eye.Health effect - clinical code: 2140 photophobia, 2140 visual disturbance- dysphotopsia.Health effect - clinical code: 2138 diplopia, 2138 visual acuity decreased.Health effect - clinical code: 4580 cataract operation complication, 4580 conjunctival abrasion, 4580 corneal deposits, 4580 cornea verticillata, 4580 dacryostenosis acquired, 4580 retinal depigmentation, 4580 keratic precipitates, 4580 retinal drusen, 4580 retinal vein occlusion.Citation: michna, m.(2018, august 16 - 2022, october 24).Clinical evaluation of a small aperture extended depth of focus intraocular lens.Identifier (b)(4).Https://clinicaltrials.Gov/ct2/show/nct03633695.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on literature review.Article: clinical evaluation of a small aperture extended depth of focus intraocular lens a nonrandomized interventional clinical trial was done to determine the safety and effectiveness of the ic-8¿ intraocular lens (iol) implanted in one eye and a monofocal or monofocal toric iol implanted in the fellow eye in accordance with the indication (cataract and presbyopia).There were initially 548 patients, 79 of whom were considered screen failures; leaving 469 subjects who were provisionally enrolled wherein 16 patients were discontinued from the study prior to second eye implantation.A total of 453 participants were successfully bilaterally implanted in the study and were divided into experimental (cataract; n=343 patients) and control (presbyopia; n=110 patients) groups.The experimental group (n=686 eyes) were implanted with a monofocal iol (acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00, johnson & johnson vision), or monofocal toric iol (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225, johnson & johnson vision) in the first eye and the ic-8¿ iol (acusoft, inc.) in the second eye.The control group (n=220 eyes) were bilaterally implanted with monofocal iols (acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00), or monofocal toric iols (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225).Each study group (ic-8¿ iol group, control group) were assigned to astigmatism group 1 (<1.0 d) or astigmatism group 2 (1.0 d - 1.5 d) as determined by preoperative corneal astigmatism in the second eye as measured by optical biometry.Among these, only 432 patients (ic-8¿ iol group: n=331 patients, 662 eyes; control group: n=101 patients, 202 eyes) completed the study.The 21 patients who did not complete the study were either discontinued or lost to follow-up.The groups were further described as follows: all second eyes (study eyes) implanted with ic-8¿ iol in the ic-8¿ iol group (ic-8¿ iol group - 2nd eye); all first eyes (fellow eyes) implanted with an acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00, or monofocal toric iol (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225) in the ic-8¿ iol group (ic-8¿ iol group ¿ 1st eye or fellow eyes); all subjects implanted with the ic-8¿ iol in the ic-8¿ iol group (ic-8¿ iol group ¿ systemic); all second eyes implanted with an acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00, or monofocal toric iol (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225) in the control group (control group - 2nd eye); all first eyes implanted with an acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00, or monofocal toric iol (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225) in the control group (control group ¿ 1st eye); and all subjects implanted with an acrysof® iq sa60wf or tecnis® aspheric monofocal zcb00, or monofocal toric iol (acrysof® iq sa6at3, sa6at4 or tecnis® zct150 or zct225) in the control group (control group ¿ systemic).Serious adverse events included: cystoid macular edema (fellow eyes, n=4; 1.2%; control ¿ 2nd eye, n= 0.91%).Iris injury (control ¿ 2nd eye, 0.91%).Postoperative surgical interventions for the ocular adverse events included: intravitreal injection (fellow eyes, n=1, 0.3%; control ¿ 1st eye, n=1, 0.9%).Iol exchange (control ¿ 2nd eye, n=1, 0.9%; control ¿ 1st eye, n=1, 0.9%).Iol repositioning (fellow eyes, n=1, 0.3%; control ¿ 1st eye, n=1, 0.9%).Iris reposition (control ¿ 1st eye, n=1, 0.9%).Laser retinopexy (fellow eyes, n=1, 0.3%).Laser vitreolysis (control ¿ 2nd eye, n=1, 0.9%).Modified paracentesis (fellow eyes, n=3, 0.9%; control ¿ 1st eye, n=1, 0.9%).Vitrectomy (fellow eyes, n=1, 0.3%).Persistent ocular serious adverse events in fellow eyes were: cystoid macular edema (n=1, 0.3%).Iritis (n=1, 0.3%).Other postoperative serious and non-serious ocular adverse events related to device were: posterior capsule opacification (fellow eyes, n=1, 0.3%).Altered visual depth perception (fellow eyes, n=1, 0.3%).Dysphotopsia (fellow eyes, n=3, 0.9%; control group ¿ 1st eye, n=1, 0.9%).Vision blurred (fellow eyes, n=1, 0.3%).Other listed nonserious adverse events included: cataract operation complication, lens dislocation (fellow eyes, n=1; control group ¿ 1st eye, n=1).Ciliary zonular dehiscence, vitreous prolapse (control group ¿ 1st eye, n=1).Conjunctival edema (fellow eyes, n=1).Conjunctival hemorrhage (fellow eyes, n=3).Conjunctival abrasion (control group - 2nd eye, n=1).Conjunctivitis (fellow eyes, n=4; control group - 2nd eye, n=2; control group ¿ 1st eye, n=1).Corneal abrasion (control group - 2nd eye, n=2; control group ¿ 1st eye, n=2).Corneal deposits, cornea verticillata (fellow eyes, n=1).Corneal dystrophy (fellow eyes, n=3).Corneal epithelial microcysts (fellow eyes, n=1).Corneal stromal edema (control group - 2nd eye, n=1).Cystoid macular edema (fellow eyes, n=3; control group ¿ 1st eye, n=1).Dacryostenosis acquired (fellow eyes, n=1).Detachment of retinal pigment epithelium, retinal depigmentation (control group ¿ 2nd eye, n=1; control group ¿ 1st eye, n=1).Diplopia (fellow eyes, n=2).Dry eye (fellow eyes, n=26; control group ¿ 2nd eye, n=9; control group ¿ 1st eye, n=9) dysphotopsia (fellow eyes, n=3; control group ¿ 2nd eye, n=1; control group ¿ 1st eye, n=2).Eye irritation (fellow eyes, n=1; control group ¿ 2nd eye, n=1).Eye pain (fellow eyes, n=1; control group ¿ 2nd eye, n=1; control group ¿ 1st eye, n=1).Eye pruritus (fellow eyes, n=2).Eyelid infection (fellow eyes, n=2).Foreign body in eye (fellow eyes, n=1).Intraocular pressure increased (fellow eyes, n=16; control group ¿ 2nd eye, n=10; control group ¿ 1st eye, n=7).Iritis (fellow eyes, n=7; control group ¿ 2nd eye, n=5; control group ¿ 1st eye, n=2).Keratic precipitates (fellow eyes, n=1).Ocular discomfort (fellow eyes, n=1).Photophobia (fellow eyes, n=1).Posterior vitreous detachment (fellow eyes, n=8; control group ¿ 1st eye, n=4).Posterior capsule opacification (fellow eyes, n=48; control group ¿ 2nd eye, n=19; control group ¿ 1st eye, n=1).Posterior capsule tear (control group ¿ 2nd eye, n=1; control group ¿ 1st eye, n=1) punctate keratitis (fellow eyes, n=1; control group ¿ 2nd eye, n=3; control group ¿ 1st eye, n=2).Retinal drusen (control group ¿ 2nd eye, n=1; control group ¿ 1st eye, n=1).Retinal tear (fellow eyes, n=1).Retinal vein occlusion (fellow eyes, n=1).Uveitis (intermediate) (fellow eyes, n=1).Vision blurred (fellow eyes, n=3).Visual acuity reduced (fellow eyes, n=1).Vitreoretinal traction syndrome (control group ¿ 1st eye, n=1).There were no further interventions reported.It is unclear if the complaints reported were caused by the j&j devices or the other devices used in the study.A copy of the article is provided with this report.This report is for model zcb00 adverse events.Separate reports are being submitted to capture the adverse events for model zct225 and model zct150.Separate reports are also being submitted to capture the product problem for models zct150, zct225, and model zcb00.

Manufacturer Narrative

Corrected data: on 4/17/2023, product identifiers with serial numbers (sn) were provided with affected eyes.There were no serious injuries (sis) for the iol model zcb00.Therefore, this event is no longer reportable.No further information will be provided under manufacturer report number 3012236936-2023-00528.Below are the manufacturer report numbers related to this literature article.Model zct150 serious injury report- manufacturer report number 3012236936-2023-00525.Model zcb00 serious injury report- manufacturer report number 3012236936-2023-00528.Model zct225 serious injury report-manufacturer report number 3012236936-2023-00529.Model zct150 malfunction report- manufacturer report number 3012236936-2023-00504.Model zcb00 malfunction report- manufacturer report number 3012236936-2023-00505.Model zct225 malfunction report- manufacturer report number 3012236936-2023-00506.This specific event will continue to be reported under this mdr 3012236936-2023-00506.Since product identifiers and affected eyes were provided per the guidance given by the fda mdr policy response line on 5/5/2023, a new manufacturer report number 3012236936-2023-01227 is being submitted.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: 16457525
• MDR Text Key: 310410362
• Report Number: 3012236936-2023-00528
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: UNK-ZCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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