MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number UNK-ZCT

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: early postoperative rotational stability and its related factors of a single-piece acrylic toric intraocular lens a retrospective study was done to evaluate the early postoperative rotational stability of tecnis toric intraocular lens (iol) and analyze its correlation with preoperative and intraoperative parameters.A total of 102 eyes of 87 patients underwent phacoemulsification and implantation with tecnis toric iol (amo).At 3 months post-op, 70 eyes had a toric iol rotation of =5.0 degrees, 27 had a toric iol rotation of 5.1-10 degrees, 3 eyes had a toric iol rotation of 10.1-15 degrees and 2 eyes had a toric iol rotation of >15 degrees.There was a special case in this study where the toric iol of this patient was rotated 73° at 1 week and 81° at 1 month after surgery.The iol repositioning was performed again around 40 days as treatment after cataract surgery, after which the iol remained stable.The mean residual astigmatism (ras) was -0.84 ± 0.88 d (ranging from 0 to -2.50 d) at 1 month and -0.81 ± 0.89 d (ranging from 0 to -2.50 d) at 3 months.A copy of the article is provided with this report.

Manufacturer Narrative

Age/date of birth (months): age range between 64.38 ± 13.75 (30¿84) years of age.Sex/gender: 51 males and 36 females.Weight & ethnicity: information unknown, not provided.Date of event: the date article was published july 12, 2019.Model number: unknown, information 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: a complete udi number is unknown, as the serial number was not provided.Implant date: exact date unknown/not provided.Best estimate date is between july 2016 to november 2017.Explant date: not applicable, as lens was not explanted.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.Device manufacture date: unknown, as the serial number was not provided.Citation: li,s., li, x., he, s., zheng, q., chen, x., wu, x., xu, w.(2019).Early postoperative rotational stability and its related factors of a single-piece acrylic toric intraocular lens.The royal college of ophthalmologists; issue & volume: 34(1), pp.474¿479.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13981933
• MDR Text Key: 292053903
• Report Number: 3012236936-2022-00842
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-ZCT
• Device Catalogue Number: UNK-ZCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/01/2022
• 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