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

Model Number UNKNOWN

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

Patient Problems Capsular Contracture (1761); Inflammation (1932); Insufficient Information (4580)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: age at surgery, mos, median (range): bilateral cataract 4 (0.7-23), unilateral cataract 7 (0.5-23).Patient weight: unknown/ not provided.Ethnicity: missing (bilateral cataract / unilateral cataract): 3 / 2, white british/irish (bilateral cataract / unilateral cataract) 36 (63%) / 37 (77%).Date of event: exact dates not provided, article acceptance date is february 27, 2020 model number: the exact mode is unknown as product serial number was not provided.Serial number : unknown/not provided.Expiration date: unknown as product serial number was not provided.Udi #: a complete udi # is unknown as product serial number was not provided.Implant date: unknown, information not provided.Explant date: not applicable, there is no indication that the lens was explanted.Manufacturer date is unknown as product serial number was not provided.(b)(4).Citation: solebo, a.L., phd, frcophth, rahi, j.S., phd, frcophth, visual axis opacity after intraocular lens implantation in children in the first 2 years of life: findings from the iolunder2 cohort study.Ophthalmology.September 2020;127(9):pp.1220-1226 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: visual axis opacity after intraocular lens implantation in children in the first 2 years of life.A prospective, observational, longitudinal study was done to describe the predictors of visual axis opacity (vao) after primary intraocular lens (iol) implantation for unilateral or bilateral congenital or infantile cataract in children younger than 2 years of age.A total of 162 eyes of 105 children (n=57 bilateral cataract (114 eyes) and n=48 unilateral cataract) underwent primary intraocular lens implantation.The iol models implanted at primary surgery were amo sensar (n=2 bilateral and n=0 unilateral; abbott medical optics), tecnis (n=2 bilateral and n=0 unilateral; amo); acrysof ma60 (n=52 bilateral and n=20 unilateral; novartis), acrysof ma30 (n=26 bilateral and n=6 unilateral), acrysof sn60iq (n=15 bilateral and n=12 unilateral), acrysof sa60 (n=15 bilateral and n=9 unilateral); hoya af (n=1 unilateral; chino hills, ca); and rayner c-flex (rayner).Of the 114 eyes with bilateral cataract, vao occurred in 47 eyes (n=13 pupillary fibrinous membrane, n=33 proliferative, and n=3 anterior capsular phimosis).For the 13 eyes that had not undergone primary capsulotomy and anterior vitrectomy (excluded from the study), 9 children with bilateral cataract needed surgical intervention for vao.A postoperative fibrinous response was noted postoperatively in 22 eyes of children with bilateral cataract.Eleven (11) eyes had resolution of the inflammation using additional topical steroids alone and 2 eyes required intraocular tissue plasminogen injection.A total of 7 eyes underwent =2 surgical corrections for vao.It is not clear if these complications occurred in the eyes implanted with sensar, tecnis or the other products.This report is for the reported adverse events occurred with the tecnis intraocular lens.A separate report is being submitted for the sensar intraocular lens.

• 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11736226
• MDR Text Key: 248370384
• Report Number: 2648035-2021-07706
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-TECNIS IOL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• 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