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

Model Number ZMB00

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

Patient Problems Corneal Edema (1791); Macular Edema (1822); Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Literature title: comparisons of outcomes and complications of immediate sequential bilateral cataract surgery and unilateral cataract surgery in a tertiary hospital in south korea.A study was done to investigate and compare outcomes and complications of immediate sequential bilateral cataract surgery (isbcs) and unilateral cataract surgery.Among the total of 441 eyes operated on, 338 were divided into two groups: the unilateral cataract surgery group (group1, n=77 eyes) and the isbcs group (group2, n=261 eyes).Four types of intraocular lens (iols)implanted included: monofocal iol (tecnis 1-piece zcb00 iol; johnson & johnson vision care, inc., jacksonville, fl, usa), extended depth-of-focus (edof) iol (tecnis eyhance icb00; johnson & johnson vision care, inc.), multifocal iol (tecnis multifocal zmb00; johnson & johnson vision care, inc.), and toric iol (tecnis toric zct; johnson & johnson vision care, inc.).Group 1 had implanted monofocals (n=55), multifocals (n=11), edofs (n=9) and torics (n=2); group 2 had monofocals (n=181), multifocals (n=38), edofs (n=40) and torics (n=2).Complications one month after surgery included: postoperative cornea edema (group1, n=2; group2, n= 5).Postoperative strabismus (group2, n=4).Exudative inflammatory response (group1, n=1; group2, n=2).Cystoid macular edema (cme) (group2, n=2).There were no further interventions reported.A copy of the article is provided with this report.

Manufacturer Narrative

Article acceptance date: december 21, 2022.Section d4: catalog number: partial number provided, as the serial number was not provided.Section d4: serial number, expiration date, udi number: unknown, as the serial number was not provided.Section d6a: implant date: unknown/not provided.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h4: device manufacture date: unknown, as the serial number was not provided.Section h3-other (81): the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.As the serial number is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Section h6- health effect - clinical code 4581: no code available (ey eye anatomy issue - pre-existing).Citation: suji hong; wonkyung park; youngsub eom; hyo myung kim; jong suk song; comparisons of outcomes and complications of immediate sequential bilateral cataract surgery and unilateral cataract surgery in a tertiary hospital in south korea; https://doi.Org/10.1038/s41598-022-26851-2.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: 17477381
• MDR Text Key: 320657432
• Report Number: 3012236936-2023-02006
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P980040
• 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: 08/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/07/2023
• 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): Other