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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Clouding/Hazing (1878)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: age, date of birth, patient weight, ethnicity, and race: unknown as information was not provided.Date of event: unknown, the best estimate date is between 03-nov-2020 and 07-jun-2021.Date explanted: not applicable as the iol remains implanted in the patient's ocular sinister (left eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patients os therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye).During follow-up appointment patient was informed that it was cloudy in there and the doctor wants to do a laser (yttrium aluminum garnet - yag) procedure to produce a hole in her lens to clear up her vision.Through follow-up additional information was received clarifying reported cloudy as the membrane (corneal opacity) had to be zapped; there was no mention of membrane inflammation.Yag procedure was performed (b)(6) 2021 and no medication was given to the but the patient was instructed not to rub her eyes.Next follow-up appointment is scheduled for (b)(6) 2021.No further information is available.
Additional Manufacturer Narrative
Corrected data: in further review of the file, it was noted that an incorrect date (09-jun-2021) was inadvertently entered in section 'g3 - date received by manufacturer' of the initial mdr report.The correct date which should have been entered is '23-jun-2021' which is the date that the follow-up information regarding yag procedure was received; therefore, the information has been corrected in this supplemental mdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12140806
• Report Number: 2648035-2021-08061
• Device Sequence Number: 4259353
• Product Code: HQL
• UDI-Device Identifier: 05050474531703
• UDI-Public: (01)05050474531703(17)231227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention