MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number NGP680300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Macular Edema (1822); Intraocular Pressure Increased (1937); Retinal Detachment (2047)

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: the outcomes of cataract surgery in eyes with fuchs uveitis.A retrospective study was done to evaluate clinical results in eyes undergoing phacoemulsification intraocular lens (iol) implantation due to fuchs uveitis (fu) related complicated cataract.A total of 56 eyes of 55 subjects with fu underwent phacoemulsification intraocular lens (iol) implantation using the whitestar signature phacoemulsification system (amo).The subjects were divided into three groups: a hydrophilic saf6125 iol (optima fold) was implanted in 10 eyes, a hydrophobic sn60at iol (alcon) in 24 eyes, and a hydrophobic aab00 iol (abbott) in 22 eyes.Postoperative complications include 6 eyes having increased intraocular pressure that was controlled by topical 2% dorzolomid-0.5% timolol maleate in the first week after the phacoemulsification surgery, cystoid macular edema (cme) which developed in 2 eyes which regressed in the first month of follow-up with posterior subtenon triamcinolone 40 mg injection in 1 eye and intravitreal dexamethasone implant in 1 eye.Rhegmatogenous retinal detachment (rd) developed in 1 eye in the second-year follow-up.It is not clear if these complications occurred in the eyes implanted with hydrophobic aab00 iol (abbott) or the other products.Posterior capsule opacification (pco) development was observed in 13 eyes implanted with the hydrophobic aab00 iol in which yag (yttrium aluminium garnet) laser capsulotomy was performed in 11 eyes as treatment.Giant cell (gc) deposits on the iol were detected in 3 eyes in the aab00 group.This report is for the whitestar signature system, a separate report is being submitted for the aab00 lenses.A copy of an extract from the article is provided with this report.

Manufacturer Narrative

Section a2: mean age 36.8 ± 9.4 (18¿60) years.Section a3: 31 female (56.4%) and 24 male (43.6%).Section b3: date of event: exact dates not provided.Article acceptance date is december 11, 2022.Section h3-other (81): the device was not returned for analysis.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Section h6 -health effect - medical device problem code 3191: unspecified issue causing patient symptoms.Citation: özdamar erol, y.; özdemir yalçinsoy, k.; özdal,p.; the outcomes of cataract surgery in eyes with fuchs uveitis; journal of ophthalmic inflammation and infection; https://doi.Org/10.1186/s12348-022-00320-3.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17456039
• MDR Text Key: 320377205
• Report Number: 3012236936-2023-01886
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention