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

Model Number PCB00

Device Problem Break (1069)

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth, weight, ethnicity: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not inserted.Therefore not removal performed.(b)(6).Device evaluation: the intraocular lens was not available, the complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during a cataract surgery, during introduction of viscoelastic in the dedicated space, while pushing to move the implant into the injection site, the haptics were broken.There was no contact with the patient eye.The product was not available for investigation.No further information available.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco, puerto rico 00610 ; * 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco 00610 ; 7142478552
• MDR Report Key: 11103433
• MDR Text Key: 230273942
• Report Number: 2648035-2020-05012
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558328
• UDI-Public: (01)05050474558328(17)230519
• Combination Product (y/n): N
• Reporter Country Code: FP
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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